BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3180099 · Received June 4, 2013

    Report

    Report Number
    2020362-2013-00246
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Report Date
    May 6, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE; THE ALARM WAS TESTED THREE TIMES AT FIVE MIN INTERVALS WITH NEW BATTERIES AND THE ALARM POWERED UP EACH TIME WITHOUT ANY INTERMITTENCY OBSERVED. HOWEVER, THE ALARM DOES NOT SOUND WHEN THE SENSOR IS CONNECTED AND WEIGHT IS OFF THE SENSOR, WHEN THE SENSOR IS UNPLUGGED OR WHEN THE MAGNET IS REMOVED. THE RED LED ON THE NURSE CALL FIXTURE LIGHTS WHEN THE NURSE CALL FUNCTION IS TESTED. NO OTHER FUNCTIONAL TESTS CAN BE PERFORMED SINCE THE ALARM DOES NOT SOUND AT ALL. THE ALARM WAS RECEIVED WITH BATTERIES INSIDE THE UNIT AND IS VISIBLY LEAKING INSIDE THE BATTERY COMPARTMENT BUT THE BATTERY CONTACTS DO NOT HAVE CORROSION ON THEM. THE BATTERY SPRINGS ARE SLIGHTLY BENT. DELAY SWITCH IS AT 4 SECONDS. AQUALERT WATER INDICATOR LABEL IS MISSING. NOTE: INSTRUCTIONS FOR USE: DO NOT USE IF; BATTERY DOOR IS MISSING, BATTERY DOOR IS DAMAGED; ALARM CASE IS DAMAGED; OR ALARM CASE IS CRACKED. WHEN ACCESSING THE BATTERY COMPARTMENT SLIDE BATTERY DOOR OPEN AND FLIP IT UP. DO NOT ATTEMPT TO REMOVE BATTERY DOOR; IT DOES NOT SEPARATE FROM ALARM. CAREFULLY REMOVE BATTERIES TO AVOID DAMAGE TO BATTERY DOOR. INSERT FOUR (4) NEW "AA" ALKALINE BATTERIES. 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 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 POWDER RESIDUE. DO NOT USE THE ALARM IF BATTERY DAMAGE HAS BEEN DETECTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ALARM WILL NOT POWER ON. THE BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. THE CUSTOMER REPORTED THERE IS NO PHYSICAL DAMAGE TO THE OUTSIDE OF THE ALARM. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247598 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK