BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER II ALARM

    MDR report key: 2031476 · Received March 18, 2011

    Report

    Report Number
    2020362-2011-00061
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    February 22, 2011
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: EVAL FOR THE RETURNED PRODUCT SHOWS THAT WHEN TESTED USING A WORKING MODEL# 8308 SENSOR PAD THE ALARM PASSED ALL FUNCTIONAL TESTS USING EITHER RECEPTACLE. THE PIN# 1 OF THE SENSOR # 2 RECEPTACLE IS BENT AND OUT OF PLACE. MANUFACTURER REFERENCES FILE# (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE ALARM HAS POWER, BUT DOES NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR. THE BATTERIES WERE REPLACED WITH A NEW SUPPLY. CUSTOMER TESTED THE ALARM WITH A NEW SENSOR AND THE RESULTS REMAIN THE SAME. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY SITTER II ALARM KMI J. T. POSEY COMPANY 8281 NA

    Patients

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