{ "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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CORRECTION. KCI IS REPORTING THIS EVENT AS A DEVICE MALFUNCTION THAT HAS THE POTENTIAL TO RESULT IN INJURY IF IT WERE TO RECUR." }, { "mdr_text_key": "189494326", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION OBTAINED REGARDING THE DEVICE, KCI FOUND EVIDENCE THAT THE DEVICE HAD A COLLAPSED DOME. THERE IS NO INJURY ASSOCIATED WITH THIS EVENT. KCI IS REPORTING THIS EVENT FOUND DURING SERVICING OF THE UNIT AS A DEVICE MALFUNCTION THAT HAS THE POTENTIAL TO RESULT IN INJURY IF IT WERE TO RECUR. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WARNINGS KEEP V.A.C.® THERAPY ON: NEVER LEAVE A V.A.C.® DRESSING IN PLACE WITHOUT ACTIVE V.A.C.® THERAPY FOR MORE THAN TWO HOURS. IF THERAPY IS OFF FOR MORE THAN TWO HOURS, REMOVE THE OLD DRESSING AND IRRIGATE THE WOUND. EITHER APPLY A NEW V.A.C.® DRESSING FROM AN UNOPENED STERILE PACKAGE AND RESTART V.A.C.® THERAPY, OR APPLY AN ALTERNATE DRESSING AT THE DIRECTION OF THE TREATING PHYSICIAN." }, { "mdr_text_key": "189494327", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE ACTIV.A.C.¿ THERAPY SYSTEM ALLEGEDLY SELF SHUTS OFF. ON 25-FEB-2020, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS PRIOR TO PATIENT PLACEMENT. ON (B)(6) 2020, THE DEVICE WAS PLACED WITH THE PATIENT. ON 31-MAR-2020, KCI QUALITY ENGINEERING PERFORMED AN EVALUATION OF THE DEVICE. INSPECTION OF THE DEVICE FOUND THE POWER BUTTON WAS COLLAPSED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/29/2020" } ] }