BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVER THE MATTRESS SENSOR PAD

    MDR report key: 1811113 · Received August 13, 2010

    Report

    Report Number
    2020362-2010-00162
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Report Date
    July 16, 2010
    Manufacturer
    POSEY MEDICAL DEVICE LTD.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL AND HAS NOT BEEN RECEIVED. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THE SENSOR WAS FIRST PUT INTO USE ON (B)(6)2010 AND THERE'S NO ALARM TONE WHEN PRESSURE IS OFF THE SENSOR PAD. THE SENSOR WAS TESTED WITH A WORKING ALARM. THERE WAS NO VISIBLE DAMAGE TO THE SENSOR. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVER THE MATTRESS SENSOR PAD KMI POSEY MEDICAL DEVICE LTD. 8307 02262010

    Patients

    Seq Age Sex Outcome Treatment
    1 NI