BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN MEDICAL SYSTEMS SHOULDER POSITIONER

    MDR report key: 578208 · Received March 4, 2005

    Report

    Report Number
    1221538-2005-00001
    Event Type
    Malfunction
    Date Received
    March 4, 2005
    Date of Event
    February 8, 2005
    Report Date
    February 8, 2005
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Removal / Correction Number
    MOD 325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT STATED THAT THE PATIENT WAS ANESTHESTIZED AND AS THE DOCTOR WAS REPOSITIONING THE PATIENT FROM A HORIZONTAL TO AN UPRIGHT SEATED POSITION THE RIGHT SIDE OF THE CHAIR BACK DETACHED FROM THE LOWER SECTION. THE COMPLAINANT STATED THAT THERE APPEARED TO BE A BROKEN WELD WHERE THE BACK HAD DETACHED. THE DOCTOR HELD THE CHAIR BACK AND THE PATIENT IN THE UPRIGHT POSITION WHILE THE STAFF TRANSFERRED THE PATIENT TO ANOTHER TABLE WHERE THE PROCEDURE WAS COMPLETED. THE PATIENT WAS UNDER THE DOCTOR'S CONTROL DURING THIS INCIDENT AND WAS NOT ADVERSELY IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS SHOULDER POSITIONER PATIENT POSITIONING DEVICE FWZ ALLEN MEDICAL SYSTEMS A-91000-A3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention