BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIV.A.C. THERAPY SYSTEM

    MDR report key: 10083768 · Received May 22, 2020

    Report

    Report Number
    3009897021-2020-00192
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    June 28, 2019
    Report Date
    July 27, 2020
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    UDI-DI
    00878237008188
    PMA / PMN Number
    K201571
    Removal / Correction Number
    3009897021-5-15-20-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION OBTAINED REGARDING THE DEVICE, KCI FOUND EVIDENCE THAT THE DEVICE TURNED OFF AND ON DUE TO A FAULTY POWER SWITCH. THERE IS NO INJURY ASSOCIATED WITH THIS EVENT. KCI IS REPORTING THIS EVENT AS A DEVICE MALFUNCTION THAT HAS THE POTENTIAL TO RESULT IN INJURY IF THE MALFUNCTION WERE TO RECUR. MDR-3009897021-2020-00192 SENT ON 22-MAY-2020 NOTED THE FOLLOWING: B5: 23-APR-2020, KCI QUALITY ENGINEERING PERFORMED AN EVALUATION OF THE DEVICE FOUND THE POWER BUTTON WAS COLLAPSED. G5: K063692. H6 DEVICE CODE(S): 1099 - 4019. H7: H9: H10: BASED ON THE INFORMATION OBTAINED REGARDING THE DEVICE, KCI FOUND EVIDENCE THAT THE DEVICE HAD A COLLAPSED POWER SWITCH. CORRECTIONS: B5: ON 23-APR-2020, KCI QUALITY ENGINEERING PERFORMED AN EVALUATION OF THE DEVICE. IT WAS IDENTIFIED THAT THE DEVICE POWERED OFF AND ON DUE TO A FAULTY POWER BUTTON/SWITCH. G5: K201571. H6 DEVICE CODE(S): 4019. H7: RECALL. H9: 3009897021-5-15-20-001-C. H10: BASED ON THE INFORMATION OBTAINED REGARDING THE DEVICE, KCI FOUND EVIDENCE THAT THE DEVICE TURNED OFF AND ON DUE TO A FAULTY POWER SWITCH.

    Description of Event or Problem · 0

    ON 23-APR-2020, KCI QUALITY ENGINEERING PERFORMED AN EVALUATION OF THE DEVICE. IT WAS IDENTIFIED THAT THE DEVICE POWERED OFF AND ON DUE TO A FAULTY POWER BUTTON/SWITCH.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION OBTAINED REGARDING THE DEVICE, KCI FOUND EVIDENCE THAT THE DEVICE HAD A COLLAPSED POWER SWITCH. THERE IS NO INJURY ASSOCIATED WITH THIS EVENT. KCI IS REPORTING THIS EVENT 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.

    Description of Event or Problem · 1

    ON 28-JUN-2019, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE ACTIV.A.C.¿ THERAPY SYSTEM ALLEGEDLY SHUTS OFF. ON (B)(6) 2019, 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) 2019, THE DEVICE WAS PLACED WITH THE PATIENT. ON 23-APR-2020, KCI QUALITY ENGINEERING PERFORMED AN EVALUATION OF THE DEVICE FOUND THE POWER BUTTON WAS COLLAPSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546619 ACTIV.A.C. THERAPY SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDACT 00878237008188

    Patients

    Seq Age Sex Outcome Treatment
    1