BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMOTION MEDICAL, INC

    MDR report key: 3050538 · Received March 15, 2013

    Report

    Report Number
    3004082462-2013-00001
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    January 3, 2013
    Report Date
    March 13, 2013
    Manufacturer
    TRANSMOTION MEDICAL INC.
    Product Code
    GBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TMM IS CHOOSING TO REPLACE THIS DEVICE AND MONITOR AS THIS IS A VERY RARE OCCURRENCE. FIRST ON RECORD FOR TMM. ITEM HAS BEEN REPLACED AND ALL IS WORKING WELL. THE ONLY OTHER TIME WE'VE SEEN THIS IS WHEN THE BATTERY WAS CLEARLY DROPPED/MISUSED. THIS COULD HAVE BEEN THE CASE, BUT COULDN'T VALIDATE VIA PICTURES.

    Description of Event or Problem · 1

    NO INJURY REPORTED. NO PTS WERE EVENT AROUND, BUT REPORTING BASED ON POTENTIAL HAZARD. CUSTOMER CALLED TO STATE THERE WAS BATTERY ACID LEAKING FROM THE BATTERY WHILE IT WAS ON THE CHARGER (WHICH WAS LEFT ON THE CHARGER OVER THE WEEKEND). DENNIS FROM BIOMED WAS THE ULTIMATE PERSON THAT DISCARDED THE BATTERY WITHOUT RETURNING TO TMM FOR OBVIOUS REASONS. HE WASN'T SURE OF ANY ENVIRONMENTAL ISSUES ON THEIR END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110793 TRANSMOTION MEDICAL, INC TMM4 MULTIPURPOSE STRETCHER-CHARI GBB TRANSMOTION MEDICAL INC. TMM4-B 2867

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other