BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 3012791 · Received February 20, 2013

    Report

    Report Number
    2020362-2013-00085
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    January 29, 2013
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    OYS
    PMA / PMN Number
    K103817
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE THE LEFT SIDE PT ACCESS WINDOW ZIPPER SLIDER BODY IS OPEN AND A ZIPPER SLIDER IS STUCK ON THE I.V. PORT ZIPPER. NOTE: POSEY 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 WILL NOT OPEN WHEN PRESSURE IS APPLIED. INSPECT ZIPPER COILS FOR ANY KINKS OR MISALIGNMENT. TEST THAT ALL ZIPPERS OPEN EASILY AND CLOSED SECURELY AND THERE ARE NO GASPS OR OPENINGS WHEN PRESSURE IS APPLIED ALONG THE ENTIRE LENGTH OF EACH ZIPPER. ALWAYS USE ZIPPER PULL-TABS AND ENSURE THAT ZIPPERS ARE FULLY CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED WHEN AN ATTEMPT IS MADE TO ZIP THE CANOPY SHUT THE TEETH WILL NOT ALIGN, ZIPPER IS SEPARATING AND WILL NOT CLOSE. THIS WAS DISCOVERED WHILE IN USE BY THE FACILITY, BUT THE USER FACILITY DID NOT PROVIDE THE DATE THIS WAS DISCOVERED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74955 POSEY BED OYS J. T. POSEY COMPANY 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK