BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ER920W EVENT RECORDER

    MDR report key: 6190597 · Received December 20, 2016

    Report

    Report Number
    2133409-2016-00003
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 20, 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 THE INCIDENT DEVICE AND LITHIUM THIONYL BATTERIES TO EXTERNAL FAILURE ANALYSIS EXPERTS FOR INVESTIGATION. THE FAILURE ANALYSIS EXPERTS DETERMINED THAT THE BATTERIES DID NOT CAUSE THE INCIDENT SINCE THEY WERE INTACT AND DID NOT VENT AND VOLTAGE MEASUREMENTS WERE NORMAL. THE FAILURE ANALYSIS EXPERTS ALSO DETERMINED INTERNAL DAMAGE TO THE DEVICE SUCH AS MELTED COPPER APPEARED TO COME FROM AN EXTERNAL SOURCE. THE FAILURE ANALYSIS EXPERTS WERE ABLE TO REPRODUCE VERY SIMILAR DAMAGE TO A REPRESENTATIVE SAMPLE OF A DEVICE AND LITHIUM THIONYL BATTERIES BY HEATING THE DEVICE AND BATTERIES INSIDE OF A MICROWAVE OVEN. BRAEMAR DOES NOT KNOW WHETHER THE ORIGINAL INCIDENT DEVICE WAS ACTUALLY PLACED INTO A MICROWAVE OVEN NOR ARE WE ABLE CONFIRM OR DENY THE ORIGINAL INCIDENT CLAIMS MADE BY THE PATIENT. BASED ON THE OPINION OF THE EXTERNAL FAILURE EXPERTS THE DEVICE AND LITHIUM THIONYL BATTERIES WERE NOT THE CAUSE FOR THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    CARDIONET PROVIDED THE DEVICE ALONG WITH THE SINGLE USE DISPOSABLE LITHIUM THIONYL BATTERY INVOLVED IN THE EVENT TO BRAEMAR ON 12/6/2016. SINCE THE DEVICES SHOWS EVIDENCE OF THERMAL HEATING, IN WHICH THE DEVICES PLASTIC CASE SHOWS SIGNS OF MELTING, BRAEMAR IS TREATING THIS EVENT AS A REPORTABLE MALFUNCTION. THE CAUSE IS UNKNOWN AT THIS TIME. THE INVESTIGATION IS ON-GOING AT THIS TIME.

    Description of Event or Problem · 1

    BRAEMAR RECEIVED INFORMATION ON 11/21/2016 FROM CARDIONET IN WHICH A PATIENT REPORTED AN ER920W DEVICE GOT HOT WHILE WEARING IT. THE PATIENT FELT THE DEVICE GETTING HOT ON THEIR CHEST AND QUICKLY REMOVED THE DEVICE. THE PATIENT WAS NOT INJURED BY THE DEVICE HEATING IN ITSELF BUT WAS STARTLED AND DID REPORT TRIPPING AND FALLING UPON STANDING UP. WE DO NOT KNOW IF ANY INJURY OCCURRED AND ARE REQUESTING MORE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840741 ER920W EVENT RECORDER EVENT RECORDER DRG BRAEMAR MANUFACTURING, LLC WEVENT

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR