BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 3060643 · Received March 28, 2013

    Report

    Report Number
    2020362-2013-00137
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    March 4, 2013
    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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE; UNIT DID NOT POWER UP WHEN USING NEW BATTERIES OR AN EXTERNAL POWER SUPPLY. UNIT POWERS UP WHEN USING A 9V ADAPTOR. THERE IS BATTERY LEAKAGE RESIDUE ON THE BATTERY DOOR. THE GREEN OVER MOLD ON THE BACK OF THE CASE IS CUT. NOTE: INSTRUCTIONS FOR USE STATE: DO NOT USE THE POSEY KEEPSAFE DELUXE IF THE AUDIBLE ALARM DOES NOT SOUND. TAKE CARE WHEN INSTALLING NEW BATTERIES. THE ALARM WILL NOT WORK IF BATTERIES ARE INSTALLED IMPROPERLY. ALWAYS INSTALL A COMPLETELY NEW SET OF BATTERIES WHEN THE CHIRPING DUE TO LOW BATTERY POWER SOUND BEGINS. DO NOT REPLACE A SINGLE CELL, BUT ALL CELLS IN THE ALARM. DO NOT MIX OLD AND NEW BATTERIES, OR BATTERY BRANDS WITHIN A BATTERY PACK (4 BATTERIES). USE OF MIXED BATTERIES OF BATTERIES INSTALLED INCORRECTLY MAY CAUSE BATTERY DAMAGE, AND MAY DAMAGE THE ALARM. REMOVE ANY ALARM FROM USE AND SEND TO THE APPROPRIATE FACILITY AUTHORITY IF BATTERIES ARE DAMAGED OR CORRODED OR THE BATTERY COMPARTMENT HAS SIGNS OF PREVIOUS BATTERY CORROSION SUCH AS WHITE POWER RESIDUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WILL NOT POWER ON. THE CUSTOMER HAS REPLACED THE BATTERIES WITH A NEW SUPPLY AND IS NOT AWARE WHAT SENSOR IS BEING USED WITH THE ALARM. THE CUSTOMER REPORTED THAT THIS WAS DISCOVERED DURING SET UP BUT COULDN'T PROVIDE THE DATE. NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128933 POSEY KEEPSAFE DELUXE KMI J. T. POSEY CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LOT NUMBER: UNK| SENSOR MODEL: UNK