{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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 VG004203 VG004204 VG004205 VG004207  VG004208  VG004209 VG004210  VG004211  VG004212  VG004214  VG004217 VG004218  VG004219  VG004220 VG004223 VG004224  VG004225 VG004226 VG004227  VG004228  VG004229 VG004230 VG004232 VG004233  VG004234 VG004235 VG004236 VG004237 VG004238 VG004240 VG004241 VG004242 VG004243 VG004244 VG004245 VG004248 VG004249 VG004251 VG004252 VG004253 VG004254 VG004255 VG004256 VG004257 VG004258 VG004259 VG004260 VG004261 VG004262 VG004263 VG004267 VG004268 VG004275 VG004277 VG004278  VG004280 VG004284 VG004286 VG004290 VG004292 VG004907", "firm_fei_number": "2015691", "recalling_firm": "Edwards Lifesciences, Llc", "address_1": "1 Edwards Way", "city": "Irvine", "state": "CA", "postal_code": "92614-5688", "additional_info_contact": "Carla Sivak, RN\n949-250-2024", "reason_for_recall": "MAP offset errors: If users are \"slaving\" mean arterial pressure (MAP) from the bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), at times, on some bedside monitors, the Vigilance II monitor may display a MAP offset of as much as 25mmHg. Since the MAP is used in calculations of various patient parameters such as SVR,", "root_cause_description": "Software design", "action": "An Urgent Customer notification letter dated May 17, 2007 was mailed to all Vigilance II customers advising that If they are \"slaving\" mean arterial pressure (MAP) from their bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), to be aware that at times, on some bedside monitors, the Vigilance II monitor may display a MAP offset of as much as 25 mmHg. Since the MAP is used in calculations of various patient parameters such as SVR, these may also not be accurate. A table is provided showing those bedside monitors with the problem: GE Solar, Phillips (HP) M1006A, M1006B, as well as, those bedside monitors verified to not have the problem: SpaceLabs Model 90402 and Nihon Kohden Model BSM 8000. The letter also serves to remind the customer of the Warning in the Vigilance II Directions for Use which is also provided in the letter that instructs user to verify slaved MAP values with those displayed on bedside monitor. A temporary work around for this offset problem is to manually enter the MAP based on the readings from the bedside monitor. All Vigilance II calculations from the MAP have been re-verified to be correct when the MAP is accurate. The problem is in the transfer of the MAP between the bedside monitor and the Vigilance II. Customers are also advised that if they have the GE Solar or the Phillips (HP) models listed in the letter or any monitor not listed as verified to be compatible with the Vigilance II (Space labs and Nihon Kohden models listed above) Edwards recommends verification of MAP accuracy prior to treating based on parameters from a Vigilance II in a \"slave\" configuration. If there is a difference, they should enter the MAP into the Vigilance II manually for a static calculation of SVR. Edwards will be supplying a software update to correct this problem.", "product_quantity": "2,680 units in North America distribution", "distribution_pattern": "Worldwide: USA and Canada", "openfda": { "k_number": [ "K192169", "K820820", "K862261", "K790288", "K872529", "K810170", "K251275", "K844277", "K833395", "K970784", "K781805", "K844682", "K131588", "K810177", "K844665", "K831967", "K042144", "K770179", "K802316", "K830892", "K112448", "K913358", "K842706", "K863153", "K812638", "K902628", "K865101", "K792080", "K833913", "K043103", "K760532", "K832644", "K962128", "K122247", "K771924", "K760756", "K896930", "K771718", "K943256", "K163334", "K843555", "K060898", "K962918", "K760774", "K840439", "K870934", "K841401", "K830003", "K113821", "K212529", "K000664", "K100709", "K760844", "K861437", "K897004", "K791753", "K781855", "K761166", "K955417", "K193179", "K812515", "K844022", "K032997", "K073113", "K023960", "K854136", "K001762", "K131048", "K883855", "K880258", "K813020", "K862808", "K791756", "K781535", "K833914", "K854371", "K122121", "K863230", "K946115", "K861092", "K880301", "K895017", "K172259", "K841256", "K122400", "K134051", "K813222", "K863308", "K810851", "K040287", "K861505", "K091786", "K822972", "K790047", "K853018", "K152935", "K894234", "K870375", "K811062", "K841967", "K811414", "K893392", "K861543", "K772152", "K081776", "K232048", "K771666", "K871659", "K932414", "K770675", "K062134", "K812757", "K863231", "K071631", "K852900", "K831057", "K831407", "K802476", "K875167", "K820898", "K802800", "K092219", "K802198", "K830628", "K841261", "K922218", "K834408", "K822093", "K822877", "K834059", "K072735", "K810163", "K103094", "K760600", "K991775", "K880696", "K840009", "K770330", "K792678", "K850568", "K811560", "K860015", "K021874", "K110597", "K181372", "K134035", "K132528", "K842105", "K802305", "K896528", "K140017", "K060660", "K253092", "K884122", "K772158", "K822903", "K812971", "K844997", "K082308", "K812932", "K131892", "K884619", "K101487", "K190955", "K080116", "K132892", "K771991", "K842831", "K833756", "K844116", "K813223", "K901926", "K760192", "K010049", "K940415", "K961661", "K820194" ], "registration_number": [ "3008132398", "3005877899", "3021242837", "2243374", "3033589330", "9681377", "3016701404", "3005580113", "3015455735", "9610105", "1720929", "3004832480", "3010698831", "3013500228", "3016618143", "3009077524", "3011353843", "3003617485", "3007603826", "9615817", "1218950", "3004415095", "3014541700", "3008403546", "3006950086", "9610816", "3013319763", "3008729547", "3015173212", "3008483389", "3003263092", "3013783488", "3013679558", "3016585366", "2221819", "2133641", "3008716327", "3009156722", "3015418961", "1319030", "9617127", "1018233", "3012536737", "3012528160", "3010157426", "3005783425", "3009001657", "3005770916", "3015309643", "1651104", "3032916632", "2648045", "3006082230", "8010042", "9710602", "8020616", "3004519921", "3013596024", "3005004021", "1416980", "3010170586", "3000126629", "3007836437" ], "fei_number": [ "3033589330", "3005877899", "3021242837", "3016701404", "3005580113", "3015455735", "1720929", "3002807091", "3004832480", "3010698831", "3013500228", "3002807167", "3016618143", "3009077524", "3011353843", "3003617485", "3001139253", "3007603826", "1218950", "3004415095", "3005846326", "3014541700", "3008403546", "3006950086", "3013319763", "1000300598", "3008729547", "3015173212", "3008483389", "3003263092", "3002808128", "3013783488", "3013679558", "3002806476", "3016585366", "2221819", "3008716327", "3009156722", "3015418961", "1319030", "3000203466", "1018233", "3012536737", "3012528160", "1000122327", "3010157426", "3005783425", "3009001657", "3005770916", "3003513129", "3015309643", "3002737156", "3003081151", "3032916632", "2648045", "3006082230", "3002806783", "3013596024", "3005004021", "1416980", "3010170586", "3000126629", "3007836437" ], "device_name": "Computer, Diagnostic, Pre-Programmed, Single-Function", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1435", "device_class": "2" } } ] }