BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSEY SITTER SELECT

    MDR report key: 1953433 · Received December 30, 2010

    Report

    Report Number
    2020362-2010-00404
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: EVAL SHOWS THE RETURNED ALARM HAS ONE BENT BATTERY SPRING. THE ALARM WAS TESTED USING NEW BATTERIES AND POWERED-UP AND PASSED FUNCTIONAL TESTS. THE LOW BATTERY INDICATOR WAS TESTED USING A LOW VOLTAGE SOURCE AND THE LOW BATTERY INDICATOR SOUNDS CORRECTLY. THE ALARM WAS ALSO TESTED USING A TEST SENSOR PAD AND WHEN PRESSURE WAS TAKEN OFF THE SENSOR PAD, THE ALARM SOUNDS CORRECTLY. THE ALARM LIQUI LABEL HAS EVIDENCE OF MOISTURE. NOTE: THE POSEY INSTRUCTIONS FOR USE HAS A WARNING: THE POSEY ALARM IS AN ELECTRONIC DEVICE THAT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED (BENT) OR IMMERSED IN LIQUID. THE UNIT MAY STOP FUNCTIONING AS DESIGNED. (B)(4).

    Description of Event or Problem · 1

    REPORTER CALLED POSEY TO CHECK IF THE ALARM HAS A LOW BATTERY INDICATOR. TECHNICAL SERVICES CONFIRMED THAT THE ALARM HAS A CHIRP TO INDICATE LOW BATTERY. THE REPORTER STATED THAT A PT GOT OUT OF BED AND FELL. THE REPORTER WAS UNCERTAIN WHETHER THE ALARM DID NOT INDICATE LOW BATTERY OR IF THE CAREGIVERS DID NOT HEAR THE ALARM SOUND. THE REPORTER WAS CONTACTED AND PROVIDED ADD'L INFO. THE PT'S NURSE CHECKED THE ALARM PRIOR TO USE AND FOUND IT TO BE WORKING PROPERLY. THE ALARM WAS THEN PUT INTO USE WITH A FEMALE PT. THE PT WAS SITTING ON A REGULAR BED SIDE CHAIR WITH A SENSOR PAD. APPROX 15 MINUTES LATER WHEN THE NURSE CHECKED THE PT, SHE HAD FALLEN. THE NURSE DID NOT HEAR THE ALARM SOUND. THE PT FRACTURED HER HUMERUS (UPPER ARM). THE PT IS IN STABLE CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other| R