BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOSPITAL WEARABLE DEFIBRILLATOR (HWD)

    MDR report key: 11986319 · Received June 11, 2021

    Report

    Report Number
    3008642652-2021-05001
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 2, 2021
    Report Date
    June 11, 2021
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005159
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MONITOR SN (B)(4) AND ELECTRODE CABLE SN (B)(4) WERE RETURNED AND FOUND TO BE FULLY FUNCTIONAL. THERE IS NO INDICATION OF A DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO THE INAPPROPRIATE TREATMENT. INAPPROPRIATE DEFIBRILLATIONS ARE AN ANTICIPATED RISK ASSOCIATED WITH THE USE OF THE HOSPITAL WEARABLE DEFIBRILLATOR. PATIENTS ARE INSTRUCTED THROUGH ALARMS, VOICE MESSAGES, IFU, AND TRAINING TO PRESS THE RESPONSE BUTTONS TO PREVENT AN INAPPROPRIATE DEFIBRILLATION. THE CURRENT COMMERCIAL INAPPROPRIATE DEFIBRILLATION RATE IS CONSISTENT WITH THE OBSERVED RATE DURING THE PIVOTAL CLINICAL TRIAL (B)(4) (0.69% PER PATIENT-MONTH WITH 90% CONFIDENCE). A SUMMARY OF THE SAFETY AND EFFECTIVENESS DATA (SSED), INCLUDING THE INAPPROPRIATE DEFIBRILLATION SAFETY OBJECTIVE SUPPORTING FDA'S APPROVAL OF THE HWD, CAN BE FOUND AT HTTP://WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF/P010030B.PDF. THE HWD DETECTION ALGORITHM COMPLIES WITH IEC 60601-2-4 PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.

    Description of Event or Problem · 1

    THE PATIENT WAS INAPPROPRIATELY TREATED 1 TIME BY THE HOSPITAL WEARABLE DEFIBRILLATOR (HWD). THE PATIENT'S NEUROLOGICAL STATUS AT THE TIME OF THE EVENT IS UNKNOWN. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE PRESSED AFTER THE TREATMENT WAS DELIVERED. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. NO INJURY WAS REPORTED FROM THE TREATMENT. THE PATIENT WAS IN THE HOSPITAL AT THE TIME OF THE EVENT. NO DEFICIENCIES WERE ALLEGED AGAINST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877469 HOSPITAL WEARABLE DEFIBRILLATOR (HWD) WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION HWD 1000 00855778005159

    Patients

    Seq Age Sex Outcome Treatment
    1 Other