BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE NO POWER SWITCH

    MDR report key: 3063848 · Received April 3, 2013

    Report

    Report Number
    2020362-2013-00139
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    February 7, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REPORTED ISSUE WAS CONFIRMED. EVALUATION REVEALED THAT THE ALARM SOUNDS CONTINUOUSLY WHILE USING A WORKING SENSOR WITH WEIGHT APPLIED. THE RJ-11 PINS ARE LOWER THAN NORMAL, BUT ARE NOT BENT OR CROSSED. ALSO, THE UNIT BATTERY DOOR IS MISSING AND THERE IS EVIDENCE OF BATTERY LEAKAGE ON THE BATTERY SPRINGS. NOTE: POSEY INSTRUCTIONS FOR USE STATES: ALWAYS INSTALL A COMPLETELY NEW SET OF BATTERIES WHEN THE CHIRPING DUE TO LOW BATTERY POWER SOUND BEGINS. DO NOT MIX OLD AND NEW BATTERIES, OR BATTERY BRANDS WITHIN A BATTERY PACK (4 BATTERIES). USE OF MIXED BATTERIES OR BATTERIES INSTALLED INCORRECTLY MAY CAUSE BATTERY DAMAGE, AND MAY DAMAGE THE ALARM. REMOVE ANY ALARM FORM 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 POWDER RESIDUE. BATTERIES CAN EXPLODE OR LEAK AND CAUSE DAMAGE TO ALARM IF INSTALLED INCORRECTLY, FULLY DISCHARGED OR EXPOSED TO LIQUID, FIRE OR HIGH TEMPERATURES. IF BATTERY DAMAGE HAS OCCURRED, OR YOU SEE ANY CORROSION, REMOVE THE ALARM FROM USE IMMEDIATELY. AFTER CHANGING BATTERIES, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PT, AND EACH TIME BEFORE LEAVING THE PT UNATTENDED. IF THE ALARM AND/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPERLY FUNCTIONING ALARM AND/OR SENSOR. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE UNIT SOUNDS CONTINUOUSLY WHEN USED WITH THE SENSOR. CUSTOMER ALSO REPORTED THAT THE BATTERY DOOR IS MISSING. THE BATTERIES WERE REPLACED WITH A NEW SUPPLY. THE DATE WHEN THE ISSUE IS DISCOVERED WAS NOT PROVIDED. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135553 KEEPSAFE DELUXE NO POWER SWITCH KMI J. T. POSEY CO. 8374NP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CHAIR SENSOR, SQUARE, 6-MONTH: MODEL 8308, LOT/UNK