BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER SELECT

    MDR report key: 2031467 · Received March 18, 2011

    Report

    Report Number
    2020362-2011-00057
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    January 31, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL: RESULTS: EVAL FOR THE RETURNED PRODUCT SHOWS THAT WHEN TESTED USING NEW BATTERIES THE ALARM DID NOT POWER ON. THE BATTERY SPRINGS ARE BENT. THE NURSE CALL FUNCTIONS INTERMITTENTLY. THE ALARM IS AN ELECTRONIC DEVICE THAT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED (BENT) OF IMMERSED IN LIQUID. THE UNIT MAY STOP FUNCTIONING AS DESIGNED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BATTERY DOOR IS MISSING FROM THE ALARM. ALSO THAT THE ALARM MAY POWER ON INTERMITTENTLY. THE ISSUE WAS DISCOVERED PRIOR TO USE AND THERE WAS NO PT CONTACT. EVAL FOR THE RETURNED PRODUCT SHOWS THAT THE BATTERY DOOR IS NOT MISSING. THE BATTERY SPRINGS ARE BENT AND THE NURSE CALL FUNCTIONS INTERMITTENTLY.

    Devices

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

    Patients

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