BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 3100 SYS

    MDR report key: 4261802 · Received November 14, 2014

    Report

    Report Number
    3008642652-2014-03996
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    September 14, 2013
    Report Date
    November 11, 2014
    Manufacturer
    ZOLL MFG CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) WAS COMPLETED. UPON INVESTIGATION THE MONITOR WAS FULLY FUNCTIONAL. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) WAS COMPLETED. UPON INVESTIGATION THE ELECTRODE BELT WAS FULLY FUNCTIONAL. THERE WAS NO EVIDENCE OF DAMAGE TO THE ELECTRODE BELT. PER PT FLAGS, THE PT DID NOT RECEIVE A TREATMENT. MONITOR SN (B)(4): 10/2008. ELECTRODE BELT SN: (B)(4): 08/2007. BIOCOMPATIBILITY TESTING TO ISO 10993 WAS SUCCESSFULLY COMPLETED ON SKIN-CONTACTING SURFACES OF THE LIFEVEST DEVICE AS WELL AS THE BLUE DEFIBRILLATION GEL.

    Description of Event or Problem · 1

    DURING A RETROACTIVE REVIEW OF PAST COMPLAINTS FOR POTENTIAL ADVERSE EVENTS, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. ON (B)(6) 2013 THE DAUGHTER OF A (B)(6) MALE PT CONTACTED A ZOLL TERRITORY MGR (TM) TO REPORT THAT WHEN THE PT GOT OUT OF THE SHOWER, ONE OF THE BELT'S ELECTRODES BURNED AN EXISTING OPEN WOUND THAT HE HAD FROM THE ELECTRODE BELT. WHILE FOLLOWING-UP WITH THE PT, A ZOLL PT SERVICE REP (PSR) REPORTED THAT IT APPEARED THAT THE PT'S TOP LAYER OF SKIN CAME OFF. THE PT'S DAUGHTER ALLEGED THAT THERE WAS SOMETHING WRONG WITH THE PT'S EQUIPMENT. THE PT'S EQUIPMENT WAS EXCHANGED. IT IS UNK WHETHER THE PT REQUIRED MED INTERVENTION. THE CLINICAL OUTCOME OF THE WOUND IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735866 LIFEVEST WCD 3100 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MFG CORP WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other