BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 2031482 · Received March 18, 2011

    Report

    Report Number
    2020362-2011-00076
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    February 24, 2011
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ZIPPER TEETH DO NOT ALIGN. EVALUATION: RESULTS: EVALUATION FOR THE RETURNED PRODUCT SHOWS THAT WINDOWS PANEL SIDES A AND B ZIPPER SLIDER BODIES ARE OPEN. NOTE: POSEY INSTRUCTIONS FOR USE WARNINGS: ALWAYS USE THE ZIPPER PULL-TABS WHEN OPENING OR CLOSING THE ZIPPERS. NEVER TRY TO RIP A PANEL OPEN AS THIS MAY DAMAGE THE ACCESS PANEL OR THE ZIPPER SLIDER BY BENDING IT OPEN. MANUFACTURER REFERENCES FILE # (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN AN ATTEMPT IS MADE TO ZIP THE ENCLOSURE, THE TEETH DO NOT ALIGN. THE DAMAGE IS LOCATED ON THE PATIENT'S RIGHT SIDE. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY STAYSAFE BED FNL J. T. POSEY CO. 8050 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI