BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAGER DVE CEILING SERVICE UNIT

    MDR report key: 50245 · Received November 5, 1996

    Report

    Report Number
    2027060-1996-09001
    Event Type
    Other
    Date Received
    November 5, 1996
    Date of Event
    October 21, 1996
    Report Date
    October 30, 1996
    Manufacturer
    DRAGERWERK AG
    Product Code
    FQP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE PENDANT HEAD OF CEILING SERVICE UNIT SEPARATED FROM THE BEARING JOINT. TECHNICIAN AND HOSPITAL STAFF SECURED THE UNIT BY RESTING IT ON A CART SO THAT THERE WAS NO TENSION ON ANY OF THE LINES. THE PROCEDURE WAS COMPLETED WITH NO FURTHER DELAYS, COMPLICATIONS OR INTERRUPTION OF SERVICES. UPON INSPECTION, IT WAS FOUND THAT THE (4) M6X55MM BOLTS AND LOCK WASHERS WERE IN PLACE, BUT HAD BEEN UNSCREWED FROM PENDANT HEAD ROTATION BEARINGS. THE THREADED HOLES SHOW NO SIGN OF WEAR OR DAMAGE. THE LAST THREAD OF (1) BOLT WAS PULLED OFF IN THE SEPARATION. TOTAL SEPARATION WAS 4" AND OCCURRED AT LOCATION B. ALL NECESSARY REPAIRS WERE COMPLETED, AND INSPECTIONS WERE MADE OF ALL OTHER UNITS IN THE HOSPITAL. UPON INSPECTION, IT WAS FOUND THAT UNITS HAD HAD ADDITIONAL PORTS INSTALLED WITHOUT CO'S SUPERVISION OR SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER DVE CEILING SERVICE UNIT CEILING SERVICE UNIT FQP DRAGERWERK AG DVE 4002-700MM/600MM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other