BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 2112236 · Received April 29, 2011

    Report

    Report Number
    2020362-2011-00139
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    March 14, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - HOLD FUNCTION ISSUE. EVALUATION: RESULTS - EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE BATTERY SPRINGS ARE BENT, HOWEVER, THE BATTERY DOES SEAT PROPERLY IN THE ALARM AND THE ALARM DOES HAVE POWER. THERE WAS NO ISSUE FOUND WITH THE HOLD OR POWER-UP FUNCTIONS. THE EVALUATION FINDINGS ARE CONSISTENT WITH THAT OF USER HANDLING RELATED ISSUES AS NOTED IN THE POSEY INSTRUCTIONS FOR USE WHICH HAS A WARNING STATEMENT: WHEN INSTALLING BATTERIES TAKE CARE NOT TO DAMAGE BATTERY CONTACTS. MANUFACTURER REFERENCES FILE # (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ALARM HAS NO POWER AND DOESN'T DETECT ANY VISIBLE DAMAGE TO THE ALARM. THERE WAS NO PATIENT INVOLVEMENT. MORE INFORMATION WAS RECEIVED ON THE RETURNED PRODUCT WHICH READS: CAN'T GET OFF HOLD - UNRESPONSIVE NOT WORKING.

    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 NA