BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 2000094 · Received February 3, 2011

    Report

    Report Number
    2020362-2011-00025
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Report Date
    December 16, 2010
    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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE ALARM DID NOT GET HOT DURING TESTING. THE ALARM DID POWER ON BUT THERE IS NO ALARM TONE WHEN PRESSURE IS TAKEN OFF OF THE SENSOR PAD, WHEN THE PAD WAS DISCONNECTED OR WHEN THE MAGNET WAS REMOVED. WHEN THE VOLUME BUTTON WAS PRESSED, THE ALARM DID SOUND AND ALL FUNCTIONS WORKED FINE EXCEPT THE LOW BATTERY CHIRP WAS SOUNDING WHILE USING NEW BATTERIES. THERE IS ONE BENT BATTERY SPRING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE ALARM HAS POWER BUT WHEN THE SENSOR WAS CONNECTED TO THE ALARM, IT WILL SOUND BUT GETS REALLY HOT. THE CUSTOMER INSERTED NEW BATTERIES IN THE ALARM TO TEST AND THEN IT WAS DETERMINED THAT THE ALARM HAD NO POWER. CUSTOMER BELIEVED THIS HAPPENED AFTER THE ALARM GOT VERY HOT. ALSO, THE BATTERY CONTACTS ARE DAMAGED. THERE IS NO CORROSION OR LEAKAGE DETECTED IN THE BATTERY COMPARTMENT. THERE WAS NO INJURY TO THE PATIENT OR PERSONNEL REPORTED. INSPECTION OF THE PRODUCT FOUND THAT THE ALARM DOES POWER ON BUT HAS NO ALARM TONE WHEN WEIGHT IS OFF THE SENSOR PAD, WHEN THE PAD IS UNPLUGGED OR WHEN THE MAGNET IS REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SQUARE CHAIR SENSOR PAD: MODEL 8308, LOT #: UNK