BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2725474 · Received August 22, 2012

    Report

    Report Number
    2020362-2012-00510
    Event Type
    Malfunction
    Date Received
    August 22, 2012
    Report Date
    July 25, 2012
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL, BUT HAS NOT YET BEEN RECEIVED. NOTE: THIS SUBMISSION IS BASED SOLELY ON THE USER FACILITY STATEMENT. NOTE: POSEY INSTRUCTIONS FOR USE WARNING STATEMENT: TAKE CARE WHEN INSTALLING NEW BATTERIES. THE ALARM WILL NOT WORK IF BATTERIES ARE INSTALLED IMPROPERLY. DO NOT MIX OLD AND NEW BATTERIES, OR BATTERY BRANDS WITHIN A BATTERY PACK. ALWAYS INSTALL A COMPLETELY NEW SET OF BATTERIES. DO NOT ALLOW BATTERIES TO DEPLETE WHILE IN THE ALARM. DEPLETED BATTERIES MAY LEAK AND CORRODE, CAUSING DAMAGE TO THE ELECTRONICS AND RELIABILITY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE UNIT HAS CORROSION ON THE BATTERY TERMINALS. NO OTHER PHYSICAL DAMAGE WAS REPORTED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY KEEPSAFE DELUXE KMI J. T. POSEY COMPANY 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SINGLE PT USE CHAIR PAD SENSOR: MODEL 8309,| LOT # UNK