BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ER920W EVENT RECORDER

    MDR report key: 6058085 · Received October 26, 2016

    Report

    Report Number
    2133409-2016-00002
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Report Date
    September 28, 2016
    Manufacturer
    BRAEMAR MANUFACTURING 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 PROVIDED ALL THE INCIDENT ITEMS TO AN EXTERNAL FAILURE ANALYSIS EXPERT FOR INVESTIGATION. THE INVESTIGATION WAS INCONCLUSIVE FOR THE ROOT CAUSE OF THE FAILURE, DUE TO THE SEVERITY OF THE DAMAGE TO THE BATTERY.

    Additional Manufacturer Narrative · 1

    CARDIONET PROVIDED THE DEVICE TO BRAEMAR ON (B)(6) 2016. SINCE DAMAGE TO THE DEVICE HAS BEEN CONFIRMED BRAEMAR IS TREATING THIS EVENT AS A REPORTABLE MALFUNCTION. AT THIS TIME THE CAUSE IS UNKNOWN. INVESTIGATION TO DETERMINE A CAUSE IS UNDERWAY.

    Description of Event or Problem · 1

    BRAEMAR RECEIVED INFORMATION ON 09/28/2016 FROM CARDIONET IN WHICH THEY REPORTED A SINGLE USE DISPOSABLE LITHIUM THIONYL BATTERY INSTALLED IN A DEVICE EXPLODED. THE PATIENT WAS NOT WEARING THE DEVICE WHEN THE INCIDENT OCCURRED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710126 ER920W EVENT RECORDER EVENT RECORDER DRG BRAEMAR MANUFACTURING LLC

    Patients

    Seq Age Sex Outcome Treatment
    1