BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 2896461 · Received November 20, 2012

    Report

    Report Number
    2020362-2012-00659
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    November 6, 2012
    Manufacturer
    J. T. POSEY CO.
    Product Code
    OYS
    PMA / PMN Number
    K113355
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. THE ZIPPER SLIDER BODY IS OPEN ON THE PANEL SIDE. AN ACCESS WINDOW WHICH CAN CAUSE THE ZIPPER TEETH TO NOT STAY ALIGNED CORRECTLY WHEN ZIPPED CLOSED. NOTE: INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: NEVER TRY TO RIP A PANEL OPEN, AS THIS MAY DAMAGE THE ACCESS PANEL OR THE ZIPPER SLIDER BY BENDING IT OPEN. NEVER USE THE BED IF A ZIPPER SLIDER IS BENT OPEN OR DAMAGED, AS THIS MAY PREVENT THE ZIPPER FROM CLOSING SECURELY. NEVER LEAVE THE PT'S BEDSIDE UNTIL ALL ACCESS PANEL ZIPPERS ARE SECURELY CLOSED. TEST THE ENTIRE LENGTH OF EACH ZIPPER BY PRESSING AGAINST THE PANEL NEAR THE SIPPER TO MAKE SURE IT IS SECURELY CLOSED AND THE ACCESS PANEL WILL NOT OPEN WHEN PRESSURE IS APPLIED. INSPECT ZIPPER COILS FOR ANY KINKS OR MISALIGNMENT. TEST THAT ALL ZIPPERS OPEN EASILY AND CLOSE SECURELY AND THERE ARE NO GAPS OR OPENINGS WHEN PRESSURE IS APPLIED. INSPECTED ZIPPER COILS FOR ANY KINKS OR MISALIGNMENT. TEST THAT ALL ZIPPERS OPEN EASILY AND CLOSE SECURELY AND THERE ARE NO GAPS OR OPENINGS WHEN PRESSURE IS APPLIED ALONG THE ENTIRE LENGTH OF EACH ZIPPER. ALWAYS USE ZIPPER PULL-TAGS AND ENSURE THAT ZIPPERS ARE FULLY CLOSED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE TEETH WILL NOT ALIGN CORRECTLY ON THE LEFT SIDE PANEL. THEY ALSO WANT THE BOTTOM STRAP TO BE REPLACED ON THE UNIT. THE CUSTOMER DID NOT SPECIFY THE DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY BED OYS J. T. POSEY CO. 8060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK