BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ER920W EVENT RECORDER

    MDR report key: 7245554 · Received February 6, 2018

    Report

    Report Number
    2133409-2018-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    January 8, 2018
    Report Date
    February 6, 2018
    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 · 0

    MULTIPLE UNSUCCESSFUL REQUESTS FOR RETURN OF THE INCIDENT BATTERY AND DEVICE WERE MADE. BRAEMAR CANNOT TAKE FURTHER ACTION AT THIS TIME SINCE THE ITEMS HAVE NOT BEEN RETURNED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION, IT IS BELIEVED THE CAUSE OF THE BATTERY MALFUNCTION WILL MOST LIKELY NOT BE ABLE TO BE DETERMINED DUE TO THE DAMAGE TO THE BATTERY SHOWN IN THE PHOTO'S PROVIDED. UPON REVIEW OF 2018 AND 2017 COMPLAINTS, THIS WAS THE FIRST REPORTED EVENT IN 2018. PREVIOUS TO 2018 THERE WERE TWO SIMILAR EVENTS REPORTED TO THE FDA VIA MDRS 2133409-2016-00002 AND THIS REPORT. (B)(4). UPON RETURN OF THE DEVICE ASSOCIATED WITH THIS EVENT, AN EVALUATION WILL BE PERFORMED WITH AN EXTERNAL FAILURE ANALYSIS EXPERT, AND A SUPPLEMENTAL MDR WILL BE SUBMITTED WITH ANY NEW RESULTS. PRIOR TO THIS REPORTED EVENT, BRAEMAR IMPLEMENTED IN EARLY 2018 THE OPTION TO UTILIZE RECHARGEABLE BATTERIES THAT ARE LESS PRONE TO RUPTURE TO FURTHER REDUCE THE POTENTIAL FOR FUTURE EVENTS TO OCCUR.

    Description of Event or Problem · 1

    BRAEMAR RECEIVED INFORMATION ON 01/08/2018 FROM OUR DISTRIBUTOR IN WHICH THEY REPORTED AN ADVERSE INCIDENT INVOLVING ONE OF THE BRAEMAR ER920W EVENT RECORDERS AND A DISPOSABLE LITHIUM THIONYL CHLORIDE BATTERY. THE DISTRIBUTOR INFORMED BRAEMAR A BATTERY RUPTURED/EXPLODED IN THE DEVICE IN A PATIENTS HOME. THE PATIENT WAS NOT WEARING THE DEVICE AT THE TIME, AND NO PATIENT INJURY WAS REPORTED. AS THE RESULT OF THE REVIEW OF PHOTOS RECEIVED OF THE RUPTURED BATTERY AND RESULTING DAMAGE TO THE DEVICE, IT WAS DETERMINED THIS EVENT COULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS EVENT IF IT WERE TO RECUR, AND IS THEREFORE BEING REPORTED TO THE FDA PER 21 CFR 803 AS AN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89301 ER920W EVENT RECORDER EVENT RECORDER DRG BRAEMAR MANUFACTURING LLC WEVENT

    Patients

    Seq Age Sex Outcome Treatment
    1