BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 1372058 · Received February 18, 2009

    Report

    Report Number
    2020362-2009-00048
    Event Type
    Malfunction
    Date Received
    February 18, 2009
    Report Date
    January 19, 2009
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: THE ALARM CASE IS DAMAGED AND THE BATTERY CONNECTORS INSIDE THE UNIT ARE DAMAGED.

    Description of Event or Problem · 1

    THE REPORTER DID NOT STATE THE REASON FOR THE RETURN OF THE SITTER SELECT ALARM MODEL 8361. THERE WAS NO PATIENT CONTACT OR INJURY REPORTED. INSPECTION SHOWS THAT THE ALARM HAS DAMAGE WHICH COULD POTENTIALLY CAUSE THE ALARM TO WORK INTERMITTENTLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI