BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 1914077 · Received November 19, 2010

    Report

    Report Number
    2020362-2010-00368
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Report Date
    October 4, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THAT THERE IS AN EXCESSIVE AMOUNTS OF BATTERY ACID INSIDE THE BATTERY COMPARTMENT AND NO FURTHER TESTING COULD BE PERFORMED. THERE WAS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM CASE. NOTE: THE INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: DO NOT MIX OLD AND NEW BATTERIES OR BATTERY BRANDS. THIS MAY CAUSE RUPTURE OR LEAKAGE AND DAMAGE ALARM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS THAT THE ALARM HAD NO POWER WHEN TESTED WITH NEW BATTERIES ALL OF THE SAME BRAND AND WITH NEW SENSOR PADS. THE CUSTOMER DID NOT SEE ANY VISIBLE DAMAGE ON THE ALARM CASE. THIS WAS DISCOVERED DURING SET UP, AND THERE WAS NO PATIENT CONTACT. INSPECTION OF THE PRODUCT FOUND THAT THERE IS BATTERY ACID INSIDE THE BATTERY COMPARTMENT.

    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 LOT# UNK| SQUARE CHAIR SENSOR PAD, MODEL #8308, LOT# UNK| OVER-THE-MATTRESS SENSOR PAD, MODEL #8307