BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS/APOLLO

    MDR report key: 1931112 · Received November 3, 2010

    Report

    Report Number
    9611500-2010-00044
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    September 3, 2010
    Report Date
    October 27, 2010
    Manufacturer
    DRAGER MEDICAL GMBH
    Product Code
    BSZ
    PMA / PMN Number
    K042607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PARTS OF THE BROKEN HINGED ARM HAVE BEEN REQUESTED FOR INVESTIGATION AT MFR SITE AND WERE RECEIVED. INVESTIGATION IS ONGOING. RESULTS WILL BE REPORTED IN A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HINGED ARM (ACCESSORY TO PRIMUS/APOLLO ANESTHESIA WORKSTATION TO FEED THE CABLES AND HOSES TO THE PATIENT) SPONTANEOUSLY BROKE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMUS/APOLLO ANESTHESIA UNIT BSZ DRAGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other