BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 1893663 · Received October 22, 2010

    Report

    Report Number
    2020362-2010-00264
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 3, 2010
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - BATTERY CONNECTORS CORROSION. EVALUATION: RESULTS: EVALUATION FOR THE RETURNED PRODUCT SHOWS WHEN TESTED THE ALARM DOES NOT POWER ON. THE BATTERY CONTACTS HAVE CORROSION. THE UNIT BATTERY DOOR IS MISSING. POSEY INSTRUCTIONS RECOMMENDS: THE USE OF ALKALINE BATTERIES IN POSEY FALL ALARMS. DO NOT MIX OLD AND NEW BATTERIES, OR MIX DIFFERENT TYPES OF BATTERIES. THIS CAN CAUSE LEAKAGE RESULTING IN CORROSION TO THE ALARM UNIT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE ALARM HAS NO POWER. THE BATTERY CONNECTORS HAVE SIGNS OF CORROSION. CUSTOMER DID NOT KNOW WHEN THE PRODUCT PROBLEM WAS DISCOVERED. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED. EVALUATION FOR THE RETURNED PRODUCT SHOWS THAT THE BATTERY CONTACTS HAVE CORROSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI