BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-TECH INFORMER DELUXE AND BED PAD

    MDR report key: 3478520 · Received November 12, 2013

    Report

    Report Number
    1929691-2013-00008
    Event Type
    Injury
    Date Received
    November 12, 2013
    Date of Event
    October 10, 2013
    Report Date
    November 12, 2013
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL #: 92030. MONITOR WAS FULLY FUNCTIONALLY TESTED AND OPERATED ACCORDING TO MFR'S SPECIFICATIONS. DUE TO THE REPORT THAT THE BATTERY WAS NOT PROPERLY SEATED IN THE COMPARTMENT, THE MONITOR WAS IMPACTED AGAINST THE BENCH DURING TESTING SEVERAL TIMES TO SEE WHETHER THE BATTERY COULD BE SHAKEN LOOSE. THE BATTERY HELD IN PLACE AND CONTINUED TO POWER THE ALARM DURING BENCH TESTING. PAD WAS FOLDED AS REC'D, BUT DID NOT PROPERLY ARM THE MONITOR ON TESTING. SOME CONNECTION WAS NOTED, BUT FULL CONNECTION COULD NOT BE MADE. NO MAJOR EVIDENCE OF USER DAMAGE WAS FOUND, PAD WAS OPENED AND INSPECTED, NO MFG DEFECTS NOTED. ENGINEERING WAS CALLED TO INVESTIGATE THE PAD BECAUSE CAUSE OF NO CONNECTION COULD NOT BE LOCATED. ENGINEERING CONTINUITY TESTING REVEALED THAT THERE WAS AN INTERMITTENT OPEN CIRCUIT IN THE PAD CORD WHICH DID NOT ALLOW PROPER ARMING - LIKELY CAUSED BY CORD STRETCHING OR TWISTING. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    PT WANTED TO LAY ON THE FLOOR AND GOT OUT OF BED AND FELL. MONITOR DID NOT ALARM, AND STAFF REPORTED THAT THE BATTERY SEEMED SLIGHTLY OUT OF ALIGNMENT IN THE BATTERY COMPARTMENT. PT WAS TAKEN BY AMBULANCE TO THE HOSPITAL AND HAD A HEMATOMA ON HER FOREHEAD, BUT NO FRACTURE AND WAS ORIGINALLY SENT BACK TO THE FACILITY. THE RESIDENT LATER VOMITED ON (B)(6) 2013, AND WAS ADMITTED TO THE HOSPITAL STATUS POST FALL, WHERE THE PT STAYED FOR APPROX ONE WEEK, BUT DID NOT REQUIRE SURGICAL OR OTHER INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584627 MICRO-TECH INFORMER DELUXE AND BED PAD MONITOR, BED-PATIENT KMI STANLEY SECURITY SOLUTIONS, INC. 81791 E12207 (MONITOR)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization