BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 3100007 · Received April 26, 2013

    Report

    Report Number
    2020362-2013-00192
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    March 27, 2013
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE; A ZIPPER SLIDER IS BENT OPEN ON THE PANEL SIDE B PATIENT ACCESS WINDOW. WINDOW SIDE A THE INSERT PIN TAPE IS TORN. 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 PATIENT'S BEDSIDE UNTIL ALL ACCESS PANEL ZIPPERS ARE SECURELY CLOSED. TEST THE ENTIRE LENGTH OF EACH ZIPPER BY PRESSING AGAINST THE PANEL NEAR THE ZIPPER 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 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

    CUSTOMER REPORTED THERE IS DAMAGE TO THE ZIPPER ON THE SIDE PANEL. CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION AS TO THE SPECIFIC TYPE OF DAMAGE. CUSTOMER DID NOT PROVIDE THE DATE WHEN THIS WAS FOUND. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181975 POSEY BED OYS J. T. POSEY CO. 8060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA