BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3131724 · Received May 6, 2013

    Report

    Report Number
    2020362-2013-00210
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Report Date
    April 22, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE; BOTH THE VOICE AND TONE SOUND AS IT SHOULD, NO STATIC IS HEARD. HOWEVER, THE BATTERY SPRINGS INSIDE THE BATTERY COMPARTMENT ARE BADLY BENT. NO INTERMITTENCY OBSERVED DURING EVALUATION. THE BATTERY DOOR IS CHIPPED BUT CLOSES SECURELY. UNIT PASSES ALL FUNCTIONAL TESTS. NOTE: INSTRUCTIONS FOR USE HAS A STATEMENT ABOUT BATTERY REPLACEMENT: 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. HOLD ALARM VERTICALLY UPSIDE-DOWN TO PREVENT BATTERY SPRING FROM BENDING DURING BATTERY INSTALLATION. INSERT FOUR (4) NEW "AA ALKALINE BATTERIES. TAKE CARE NOT TO DAMAGE BATTERY CONTACTS. FLIP BATTERY DOOR DOWN. PUSH DOWN GENTLY ON BATTERIES AND SLID BATTERY DOOR CLOSED UNTIL IT CLICKS SHUT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM HAS POWER BUT DOES NOT SOUND WHEN THE OPTION TONE AND VOICE IS USED. THE CUSTOMER ONLY HEARS STATIC. CUSTOMER ALSO REPORTED THE ALARM DOES NOT WORK WITH THE TONE OPTION EITHER. THE BATTERIES HAVE BEEN REPLACED AND THERE IS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. THE CUSTOMER DID NOT PROVIDE THE DATE WHEN THIS WAS FOUND BUT REPORTED IT WAS DISCOVERED DURING SET UP. NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197909 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SITTER SELECT MAGNET: MODEL 8361, LOT # NA