BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 2031499 · Received March 18, 2011

    Report

    Report Number
    2020362-2011-00075
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    February 17, 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 WILL NOT ALIGN. THE PRODUCT HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT BEEN RECEIVED. MANUFACTURER REFERENCES FILE # (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS THAT THE ZIPPER TEETH WILL NOT ALIGN WHEN AN ATTEMPT IS MADE TO ZIP THE ENCLOSURE ON BOTH SIDE PANELS OF THE CANOPY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI