BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2505041 · Received March 1, 2012

    Report

    Report Number
    2020362-2012-00106
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Report Date
    January 24, 2012
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL OF THE RETURNED PRODUCT FOUND THE ALARM POWERS ON BUT DOES NOT TRIGGER THE NURSE CALL LIGHT TO COME ON WHEN WEIGHT IS OFF THE TEST SENSOR. THE ALARM IS MISSING THE BATTERY DOOR AND THE BATTERY SPRINGS ARE BENT. NOTE: POSEY INSTRUCTIONS FOR USE HAS A STATEMENT: PROPER HANDLING AND USE: IF THE POSEY KEEPSAFE DELUXE IS SUBJECTED TO SEVERE MECHANICAL SHOCK, SUCH AS DROPPING, OR IS SUBMERGED IN LIQUID, IT MAY STOP FUNCTIONING AS DESIGNED. VISUALLY INSPECT THE UNIT FOR CRACKS IN THE CASE, MISSING SCREWS, MISSING BATTERY DOOR, BROKEN WIRES OR SIGNS OF EXPOSURE TO LIQUID. AFTER EACH INCIDENT, YOU MUST VERIFY THAT THE UNIT IS WORKING PROPERLY. CHECK TO MAKE SURE THE AUDIBLE ALARM IS FUNCTIONING PROPERLY BY APPLYING AND LIFTING WEIGHT OFF SENSOR IN SEVERAL SPOTS TO ACTIVATE THE ALARM. DO NOT USE THE POSEY KEEPSAFE DELUXE IF THE AUDIBLE ALARM DOES NOT SOUND. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY HAVE AN ALARM THAT HAS DAMAGES BUT COULDN'T PROVIDE EXACTLY WHAT THE PRODUCT ISSUE WAS. THEY REPORTED POSSIBLY THE ALARM MIGHT HAVE CORROSION AND/OR THE HOLD/SUSPEND BUTTON IS COMING OFF BUT THEY COULDN'T BE MORE SPECIFIC FOR THE REASON OF THE RETURN OF THE ALARM. THE CUSTOMER REPORTED THEY ARE CLEANING THE ALARM WITH SUPER SANI WIPES AND ARE NOT REUSING THE BATTERIES BETWEEN PTS. THERE WAS NO PT INJURY REPORT.

    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 UNK