BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 1821298 · Received August 26, 2010

    Report

    Report Number
    2020362-2010-00189
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Report Date
    July 14, 2010
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ALARM, FAILURE TO. RESULTS - EVALUATION FOR THE RETURNED PRODUCT SHOWS THAT WHEN TESTED THE ALARM POWERED ON, BUT THERE WAS NO ALARM TONE WHEN PRESSURE IS TAKEN OFF THE SENSOR PAD OR WHEN THE SENSOR IS DETACHED FROM THE ALARM. THE ALARM UNIT SCREWS ARE RUSTED AND THE LIQUID LABEL SHOWS EVIDENCE OF MOISTURE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS DURING SET-UP THAT THE ALARM HAS POWER, BUT NO ALARM TONE WHEN PRESSURE IS OFF THE PAD. THERE IS NO ALARM TONE WHEN THE SENSOR IS DETACHED FROM THE ALARM. THE ALARM WAS TESTED WITH NEW BATTERIES AND A TEST STRIP. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY KEEPSAFE DELUXE KMI J. T. POSEY CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI