BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ER920W EVENT RECORDER

    MDR report key: 4729804 · Received April 24, 2015

    Report

    Report Number
    2133409-2015-00002
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Date of Event
    March 25, 2015
    Report Date
    March 25, 2015
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DRG
    PMA / PMN Number
    K072008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BRAEMAR PROVIDED ALL THE INCIDENT ITEMS TO AN EXTERNAL FAILURE ANALYSIS EXPERT FOR REVIEW. THE ROOT CAUSE OF THE FAILURE WAS NOT DETERMINED, DUE TO THE DAMAGE SEVERITY OF THE ITEMS.

    Additional Manufacturer Narrative · 1

    CARDIONET PROVIDED DIGITAL PHOTOGRAPHS THAT SHOW EXTENSIVE DAMAGE TO THE DEVICE. CARDIONET PROVIDED THE DEVICE TO BRAEMAR ON 03/30/2015. SINCE DAMAGE TO THE DEVICE HAS BEEN CONFIRMED, BRAEMAR IS TREATING THIS EVENT AS A REPORTABLE MALFUNCTION. AT THIS TIME, THE CAUSE IS UNK. INVESTIGATION TO DETERMINE A CAUSE IS UNDERWAY.

    Description of Event or Problem · 1

    BRAEMAR RECEIVED INFO ON 03/25/2015 FROM CARDIONET IN WHICH THEY REPORTED A BATTERY INSTALLED INTO A BRAEMAR EVENT RECORDER EXPLODED AT THEIR FACILITY. THIS INCIDENT OCCURRED OVERNIGHT WHILE NO ONE WAS IN THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272514 ER920W EVENT RECORDER DRG BRAEMAR MANUFACTURING, LLC ER920W

    Patients

    Seq Age Sex Outcome Treatment
    1