BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 2490602 · Received March 6, 2012

    Report

    Report Number
    2020362-2012-00094
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Report Date
    January 25, 2012
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INSPECTION OF THE RETURNED PRODUCT REVEALED THE PT ACCESS PANEL SIDE ZIPPER SLIDER BODY IS OPEN. ALSO THE TOP RIDGE SLIDER BODY IS OPEN, A SLIDER AND A LEG PULL TAB ARE MISSING. 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 NEAR THE ZIPPER TO MAKE SURE IT IS SECURELY CLOSED AND THE ACCESS PANEL WILL NOT OPEN WHEN PRESSURE IS APPLIED. NEVER USE THE BED IF THE ZIPPER PULL-TAB IS MISSING OR BROKEN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TEETH WILL NOT ALIGN WHEN AN ATTEMPT IS MADE TO SECURE THE TEETH SHUT. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA