BEUDAMED
    FDA Adverse Event Summary report: N

    BABYTHERM 8010

    MDR report key: 2497931 · Received March 8, 2012

    Report

    Report Number
    9611500-2012-00010
    Date Received
    March 8, 2012
    Date of Event
    October 10, 2011
    Report Date
    March 8, 2012
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    FMT
    PMA / PMN Number
    K971198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER: (B)(4). IT WAS REPORTED THAT ON FOUR RADIANT WARMERS THE SWIVEL JOINT BECAME VERY STIFF AND THE SWIVEL RANGE OF THE WARMER WAS MORE AND MORE RESTRICTED. THE SWIVEL JOINTS OF THE CONCERNED DEVICES WERE REPLACED FOR REPAIR AND ONE OF THE JOINTS WAS MADE AVAILABLE FOR INVESTIGATION. THE JOINT IS DESIGNED LIKE A BIG SCREW WITH FINE PITCH THREAD, TURNING IN THE FITTING NUT. BOTH PARTS ARE MADE OF MASSIVE BRASS. IF THE WARMER IS MOVED ASIDE, THE SCREW TURNS IN THE NUT. THE RECEIVED JOINT COULD ONLY BE MOVED AND DISASSEMBLED BY APPLYING HIGH FORCES. IT WAS FOUND THAT THE JOINT WAS DAMAGED AND JAMMING AS IT WAS NOT SUFFICIENTLY LUBRICATED. THE ROOT CAUSE FOR MISSING LUBRICATION COULD NOT BE IDENTIFIED. THE REPORTED CASE IS ISOLATED. IN THE FRAME OF OUR WORLDWIDE MARKET OBSERVATION NO OTHER SIMILAR CASE WAS REPORTED. THE SPARE PART CONSUMPTION OF THE JOINTS IS NON SUSPICIOUS. IF THE WARMER CAN'T BE MOVED ASIDE, THIS HAS NO INFLUENCE ON THE BASIC FUNCTION OF THE RADIANT WARMER. IT IS OBVIOUS IF FORCE TO SWIVEL THE WARMER INCREASED BY TIME AND SERVICE SHOULD BE CALLED FOR REPAIR. THE FOUR CONCERNED JOINTS WERE ALL REPLACED AND THE WARMERS RETURNED INTO SERVICE. THIS CASE WAS ASSESSED TO BE NON REPORTABLE IN ACCORDANCE TO 21 CFR. PART 803.

    Description of Event or Problem · 1

    THIS REPORT IS FILED TO GIVE AN RESPONSE TO UFR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABYTHERM 8010 RADIANT WARMER FMT DRAEGER MEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1