BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 2010041 · Received March 2, 2011

    Report

    Report Number
    2020362-2011-00049
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 28, 2011
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE PRODUCT WAS REQUESTED TO BE RETURNED BUT HAS NOT BEEN RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A FEMALE PT WAS AT THEIR FACILITY RECOVERING FROM A PREVIOUS LEFT HIP FRACTURE. THE PT WAS SITTING IN HER CHAIR WITH A SENSOR PAD AND A SITTER SELECT ALARM. THE ALARM HAD BEEN ACTIVELY SOUNDING ALL DAY WHEN SHE WOULD ATTEMPT TO GET UP OUT OF HER CHAIR. THE STAFF WENT IN AND VERIFIED THAT THE ALARM WAS ON AND WAS NOT SET ON HOLD. LATER THAT DAY, THE STAFF WENT IN TO CHECK ON THE PT AND THEY FOUND HER ON THE FLOOR. THE ALARM WAS NOT SOUNDING. THEY TOOK HER FOR A CT SCAN WHICH SHOWED A MINOR OUTER HEMATOMA (BRUISE) ON HER HEAD BUT IT WAS NOT SERIOUS AND SHE IS RECOVERING FINE. THE REPORTER STATED THAT THEY TESTED THE ALARM'S HOLD FUNCTION AFTER THE INCIDENT AND THEY COULDN'T SEEM TO GET IT TO RESET OFF HOLD UNTIL APPROXIMATELY 3 MINUTES.

    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 NI CHAIR SENSOR PAD: MODEL UNK, LOT # UNK