BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 1370752 · Received February 13, 2009

    Report

    Report Number
    2020362-2009-00012
    Event Type
    Malfunction
    Date Received
    February 13, 2009
    Report Date
    January 15, 2009
    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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: (OTHER) -THE ALARM'S BATTERY DOOR IS DAMAGED AND THERE IS EVIDENCE OF A BATTERY ACID LEAK INSIDE THE BATTERY COMPARTMENT. MFR REFERENCE # 2009-02-02682/93278.

    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 PT CONTACT OR INJURY REPORTED. INSPECTION SHOWS THAT THERE IS A BATTERY ACID LEAK AND THE BATTERY DOOR IS DAMAGED 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 CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI