BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NPWT SVED THERAPY DEVICE

    MDR report key: 6380421 · Received March 6, 2017

    Report

    Report Number
    1423537-2017-00075
    Event Type
    Injury
    Date Received
    March 6, 2017
    Date of Event
    February 6, 2017
    Report Date
    March 6, 2017
    Manufacturer
    INNOVATIVE THERAPIES, INC. DBA CARDINAL HEALTH 248
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION AND NO FAILURE WAS FOUND UPON RECEIPT OF THE DEVICE. THE DEVICE PASSED ALL TESTS. THE FOLLOWING TESTS OF THE RETURNED DEVICE WERE TESTED AND ALL WERE FOUND TO FUNCTION AS INTENDED. THE CANISTER RELEASE LATCH, THE POWER CONNECTOR/BATTERY CHARGE INDICATOR, THE ON "I" BUTTON AND SELF-TEST, ALL LED SWITCHES AND LCD SWITCHES, THE PRESSURE SELECTION LOCKOUT, THERAPY/INTERMITTENT MODE AND VACUUM TESTS WERE ALL WITHIN SPECIFICATIONS: ¿ -70 MMHG SETTING READS AT 70.5 MMHG (WITHIN SPECIFICATIONS) ¿ -120 MMHG SETTING READS AT 119.8 MMHG (WITHIN SPECIFICATIONS) ¿ -150 MMHG SETTING READS AT 149.5 MMHG (WITHIN SPECIFICATIONS). THE LEAK ALARM TEST AND FULL CANISTER ALARM TESTS WERE TESTED AND ALL FUNCTIONED AS INTENDED. THE DEVICE ALSO PASSES THE BATTERY/PRESSURE TEST AT TIME - 16:29:52 THEREFORE IT EXCEEDS THE MINIMUM STANDARD OF 10.5 HOURS. HOWEVER, THE DEVICE WAS NOT RETURNED WITH THE POWER ADAPTER SO THAT PART OF THE TESTING IS WOULD BE DEEMED INCONCLUSIVE IF THE INCIDENT REPORTED WAS RELATED TO THE POWER DELIVERY TO THE DEVICE. WE WILL CONTINUE TO MONITOR FOR ANY SIMILAR REPORTS.

    Description of Event or Problem · 1

    PATIENT CALLED CUSTOMER SERVICE AND LEFT A VOICEMAIL MESSAGE TO REQUEST A REPLACEMENT SVED WTS (NEGATIVE PRESSURE WOUND THERAPY) UNIT BECAUSE SHE STATED THAT THE DEVICE IS NOT PUMPING (SUCTIONING) ALTHOUGH IT IS CHARGED, POWERS ON AND BATTERY INDICATOR LIGHT ILLUMINATES WHEN THE UNIT IS PLUGGED IN. PATIENT DID STATE THAT HER WOUND IS EXTREMELY MACERATED AND PER THE PATIENT SHE WAS PLACED ON A WOUND VACATION BY HER DOCTOR UNTIL THE SKIN HEALS A LITTLE MORE. PATIENT ALLEGED THAT FLUID IN THE TUBING WAS THE CAUSE OF MACERATION OF WOUND. THE DEVICE WAS REMOVED ON FRIDAY (B)(6) 2017 AND THE PATIENT HAS A DOCTORS APPOINTMENT ON (B)(6) 2017 AND THE NEGATIVE PRESSURE WOUND THERAPY ( NPWT) IS SCHEDULE TO RESUME ON THIS DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164904 NPWT SVED THERAPY DEVICE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP INNOVATIVE THERAPIES, INC. DBA CARDINAL HEALTH 248 6701132 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 Other