BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ER920W WIRELESS EVENT RECORDER

    MDR report key: 7502965 · Received May 10, 2018

    Report

    Report Number
    2133409-2018-00002
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Date of Event
    March 31, 2018
    Report Date
    April 12, 2018
    Manufacturer
    BRAEMAR MANUFACTURING LLC
    Product Code
    MLO
    UDI-DI
    B146ER9WCNC0
    PMA / PMN Number
    K072008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BRAEMAR MANUFACTURING IN NO LONGER INVESTIGATING THIS INCIDENT AND CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    (B)(6) CONTACTED BRAEMAR MANUFACTURING ABOUT A WEVENT DEVICE IN WHICH A LITH BATTERY RUPTURED IN THE DEVICE, IN A PATIENTS HOME WHILE THE DEVICE WAS SITTING ON A TABLE. NO PATIENT INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO BRAEMAR FOR EVALUATION ON 04/17/2018. 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 AND DEVICE. UPON REVIEW OF 2018 AND 2017 COMPLAINTS, THIS WAS THE SECOND REPORTED EVENT IN 2018. PREVIOUS TO 2018 THERE WERE THREE SIMILAR EVENTS REPORTED TO THE FDA VIA MDRS 2133409-2016-00002, 2133409-2016-00003, AND 2133409-2017-00001. (B)(4). 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 IN EARLY 2018, BRAEMAR HAS BEGUN TRANSITIONING TO A NEW RECHARGEABLE BATTERY OPTION TO REDUCE THE LIKELIHOOD OF FUTURE BATTERY RUPTURE EVENTS.

    Description of Event or Problem · 1

    BRAEMAR RECEIVED INFORMATION ON 04/12/2018 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 WHILE THE DEVICE WAS SITTING ON A TABLE. NO PATIENT INJURY WAS REPORTED. AS THE RESULT OF THE REVIEW OF PHOTOS RECEIVED OF THE RUPTURED BATTERY AND RESULTING DAMAGE OBSERVED ON THE RETURNED 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
    347926 ER920W WIRELESS EVENT RECORDER WEVENT MLO BRAEMAR MANUFACTURING LLC WEVENT B146ER9WCNC0

    Patients

    Seq Age Sex Outcome Treatment
    1