BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2469146 · Received February 10, 2012

    Report

    Report Number
    2020362-2012-00067
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Report Date
    January 19, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THE ALARM IS MISSING THE HOLD/SUSPEND BUTTON. THERE IS BATTERY LEAKAGE ON THE BATTERY SPRINGS AND CORROSION ON THE BATTERY CONTACTS. THERE IS SIGNS OF WATER INTRUSION. THE UNIT WILL NOT POWER ON WITH BATTERIES OR 9V BATTERIES. NOTE: POSEY INSTRUCTIONS FOR USE HAS A STATEMENT: IF THE POSEY KEEPSAFE IS SUBJECTED TO SEVERE MECHANICAL SHOCK, SUCH AS DROPPING, OR IS SUBMERGED IN LIQUID, IT MAY STOP FUNCTIONING AND 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 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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE THE ALARM WAS BEING TESTED TO BE USED ON A NEW PT, THE HOLD/SUSPEND BUTTON CAME OFF. THE CUSTOMER REPORTED THEY DID NOT MIS-HANDLE THE UNIT AND THE DAMAGED OCCURRED DURING NORMAL USE OF THE UNIT. NO OTHER DAMAGE REPORTED BY THE CUSTOMER. 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 CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA OVER-THE-MATTRESS SENSOR PAD: MODEL 8307, LOT# UNK