BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ER920W EVENT RECORDER

    MDR report key: 5258725 · Received December 1, 2015

    Report

    Report Number
    2133409-2015-00005
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Date of Event
    November 3, 2015
    Report Date
    November 3, 2015
    Manufacturer
    BRAEMAR MANFUACTURING, LLC
    Product Code
    DRG
    PMA / PMN Number
    K072008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAEMAR WAS PROVIDED DIGITAL PICTURES OF THE DEVICE FROM CARDIONET, SHOWING DAMAGE TO THE DEVICE CONSISTENT WITH A REPORTABLE MALFUNCTION. AT THIS TIME THE CAUSE IS UNKOWN. WAITING ON RETURN OF DEVICE.

    Additional Manufacturer Narrative · 1

    BRAEMAR RECEIVED THE DEVICE FOR EVALUATION ON 1/14/16. THE SINGLE USE DISPOSABLE BATTERIES WERE NOT RETURNED. THE DISTRIBUTOR HAS CONFIRMED THEY ACCIDENTLY DISPOSED OF THE BATTERIES AS WELL AS OTHER DEVICE ITEMS. BRAEMAR DID PERFORM A VISUAL EVALUATION OF THE DEVICE BUT WITHOUT THE BATTERIES COULD NOT DETERMINE A CAUSE. THE CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    BRAEMAR RECIEVED INFORMATION ON (B)(6) 2015 FROM CARDIONET IN WHICH THEY REPORTED A BATTERY INSTALLED INTO A BRAEMAR EVENT RECORDER EXPLODED IN A PATIENT'S HOME. THE PATIENT WAS NOT WEARING THE MONITOR AT THE TIME. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790295 ER920W EVENT RECORDER EVENT RECORDER DRG BRAEMAR MANFUACTURING, LLC ER920W

    Patients

    Seq Age Sex Outcome Treatment
    1