BEUDAMED
    FDA Adverse Event Other Summary report: N

    ER920W EVENT RECORDER

    MDR report key: 2101168 · Received May 19, 2011

    Report

    Report Number
    2133409-2011-00001
    Event Type
    Other
    Date Received
    May 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 22, 2011
    Manufacturer
    BRAEMAR, INC.
    Product Code
    DRG
    PMA / PMN Number
    K072008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY CELL DESIGN HAS A BUILT IN THERMAL LIMITING FUSE THAT BY DESIGN SHOULD OPEN IN THE EVENT OF HIGH ENERGY DRAW FROM THE CELL. IN DISCUSSIONS WITH THE BATTERY CELL MANUFACTURER THEY HAVE INDICATED THEY HAVE HAD PROCESS CONTROL ISSUES AND BELIEVE THAT NOT ALL OF THEIR NICKEL COATED STEEL BATTERY CASINGS ARE AS ROBUST AS ORIGINALLY INTENDED. INVESTIGATION IS ON-GOING AT THIS TIME. FOR THESE REASONS BRAEMAR HAS TAKEN FIELD ACTION AND RECOMMENDED DISCONTINUING USE OF THIS MANUFACTURER'S NON-RECHARGEABLE DISPOSABLE BATTERY CELLS. OUR CUSTOMERS HAVE BEEN PROVIDED WITH AN ALTERNATE QUALIFIED BATTERY CELL, IN BOTH NEW DEVICES SHIPPED, AS WELL AS FOR REPLACEMENT CELL USE.

    Description of Event or Problem · 1

    (B)(4) EVENT RECORDER SERIAL NUMBER (B)(4) WAS AT A PATIENT'S HOME. THE PATIENT WAS NOT WEARING THE DEVICE AND HAD LEFT THE DEVICE IN A CARRYING POUCH IN THEIR BATHROOM ON THE RIM OF THEIR BATHTUB. WHILE THE PATIENT WAS OUT OF THE ROOM THE EVENT OCCURRED. ONE LITHIUM THIONYL CHLORIDE (LITH) BATTERY CELL FROM THE BATTERY PACK PAIR BURST. EXTENSIVE DAMAGE OCCURRED TO THE BATTERY CELL, DEVICE AND CARRYING POUCH. NO INJURY OCCURRED TO THE PATIENT, NOR WAS THERE ANY DAMAGE TO SURROUNDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ER920W EVENT RECORDER DRG, MLO DRG BRAEMAR, INC. ER920W

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other