BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2031466 · Received March 18, 2011

    Report

    Report Number
    2020362-2011-00065
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    December 29, 2010
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS: EVAL FOR THE RETURNED PRODUCT SHOWS THAT WHEN THE ALARM WAS TESTED USING A WORKING 8308 SENSOR PAD THE ALARM POWERED ON, BUT THERE'S NO ALARM TONE WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD. THE ALARM SOUNDS ONLY WHEN THE SENSOR IS DETACHED. THERE IS NO VISIBLE DAMAGE TO THE ALARM. MANUFACTURER REFERENCES FILE# (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ALARM HAS POWER, BUT WHEN A SENSOR IS CONNECTED AND TESTED THE ALARM TONE HAS A REVERSE EFFECT. THE ALARM SOUNDS WHEN PRESSURE IS ON THE SENSOR PAD AND DOES NOT SOUND WHEN PRESSURE IS OFF THE SENSOR. THERE WAS NO PT INCIDENT OR INJURY REPORTED. EVAL FOR THE RETURNED PRODUCT SHOWS THAT THE ALARM POWERS ON, BUT THERE'S NO ALARM TONE WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI