BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEN UNIVERSAL HEAD POSITIONER

    MDR report key: 1881683 · Received October 20, 2010

    Report

    Report Number
    1221538-2010-00006
    Event Type
    Other
    Date Received
    October 20, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEAD POSITIONER WAS RECEIVED WITH SEVERE BREAKAGE OF THE CRADLE/BASE OF THE UNIT -DAMAGE ENGINEERING CONCLUDED WAS LIKELY TO HAVE BEEN CAUSED BY DAMAGE OR A DROP INCURRED PRIOR TO THE CASE. THERE WERE NO COMPONENT FAILURES OR MFG ISSUES NOTED. THIS FEEDBACK WAS PROVIDED TO THE CUSTOMER ON (B)(6) 2010 AND IT WAS LEARNED AT THAT TIME THAT THE BREAK WAS FIRST NOTED DURING USE AT THE BEGINNING OF A CASE, WHEN THE CRADLE BEGAN TO SPLIT. THERE WAS NO INJURY RESULTING. NO LENGTHY DELAY WAS NOTED - JUST PT INVOLVEMENT. THE DAMAGED HEAD POSITIONER WAS TAKEN OUT OF USE AND REPLACED.

    Description of Event or Problem · 1

    ALLEN MEDICAL RECEIVED A REPAIR REQUEST FOR A BROKEN HEAD POSITIONER WITH A CRACKED CRADLE. THE UNIT WAS RECEIVED FOR EVAL. THERE WAS NO PT INJURY ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN UNIVERSAL HEAD POSITIONER HEAD POSITIONER FWZ ALLEN MEDICAL SYSTEMS A-90022-A2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1