BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BED-CHECK MODEL VR MONITOR

    MDR report key: 2973532 · Received February 15, 2013

    Report

    Report Number
    1929691-2013-00001
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 4, 2013
    Report Date
    February 15, 2013
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY REPORTED THAT THE INITIAL REPORT FROM HOSPITAL STAFF WAS OF AN ALARM FAILURE. UPON FURTHER INVESTIGATION BY FACILITY, IT WAS REPORTED THAT THE SENSORMAT PAD WAS NOT SECURED TO THE BED WITH RUBBER BANDS AND CLIPS, AND THAT THE SENSORMAT PAD WAS FOUND "BUNCHED UP" AND NOT SECURED TO THE BED. FACILITY BELIEVES THAT THE SENSORMAT PAD MAY HAVE BEEN BLOODIED, WHICH WOULD EXPLAIN WHY THE SENSORMAT PAD WAS DISPOSED OF. FACILITY REPORTED HAVING CONDUCTED WALKTHROUGHS WITH THEIR BED-CHECK DISTRIBUTOR WITHIN THE LAST TWO MONTHS - DURING THOSE WALKTHROUGHS STAFF WAS REMINDED NOT TO DISPOSE OF ANY EQUIPMENT INVOLVED IN A FALL. FACILITY REPORTED THAT THE MONITOR INVOLVED IN THE FALL WAS SECURED AND TAKEN TO BIO-MED, WHERE IT WAS TESTED. THE FACILITY'S TESTING OF THE MONITOR DID NOT REVEAL ANY MALFUNCTION. FACILITY WAS ASKED TO RETURN THE MONITOR FOR EVALUATION BY MANUFACTURER, BUT FACILITY REPORTED THAT RISK MANAGEMENT HAD PLACED A HOLD ON THE MONITOR AND THAT THEY WOULD NEED TO CLEAR THE RETURN FOR INSPECTION. LATER FOLLOW-UP WITH FACILITY INDICATED THAT MONITOR WOULD NOT BE RELEASED FOR MANUFACTURER'S EVALUATION. BASED ON FACILITY'S REPORTS, MANUFACTURER SUSPECTS, BUT CANNOT COMPLETELY CONFIRM THAT THE FACILITY'S FAILURE TO PROPERLY SECURE THE SENSORMAT PAD RESULTED IN A CREASED OR FOLDED PAD THAT WOULD NOT SIGNAL EXIT ALARM. FACILITY REPORTED THAT MONITOR OPERATED CORRECTLY POST-INCIDENT. FACILITY WAS REMINDED OF IMPORTANCE OF SECURING SENSORMAT PADS IN POSITION.

    Description of Event or Problem · 1

    PATIENT WAS REPEATEDLY GETTING OUT OF BED, AFTER BEING BROUGHT TO HOSPITAL FOR BRAIN TUMORS. PATIENT WAS FOUND OUT OF BED AND THE MONITOR WAS REPORTED AS NOT SOUNDING AN ALARM. PATIENT SUFFERED SUBDURAL HEMATOMA, ORBITAL INJURIES, LACERATIONS TO HAND AND FOREHEAD, FACIAL FRACTURES. HOSPITAL BELIEVES PATIENT FELL AGAINST A DOOR FRAME. UPON FURTHER INVESTIGATION, FACILITY REPORTED THAT THE SENSORMAT PAD WAS NOT SECURED TO THE BED WITH RUBBER BANDS AND CLIPS, AND THAT THE SENSORMAT PAD WAS FOUND "BUNCHED UP" AND NOT SECURED TO THE BED. FACILITY BELIEVES THAT THE SENSORMAT PAD MAY HAVE BEEN BLOODIED, WHICH WOULD EXPLAIN WHY THE SENSORMAT PAD WAS DISPOSED OF, AND WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. FACILITY REPORTED THAT THE MONITOR INVOLVED IN THE FALL WAS SECURED AND TAKEN TO BIO-MED, WHERE IT WAS TESTED WITH NO FAILURES NOTED. PATIENT WAS DISCHARGED TO HOSPICE CARE DUE TO CANCER DIAGNOSIS. FACILITY REPORTED THAT THE PATIENT SUFFERED A SUBDURAL HEMATOMA, ORBITAL INJURIES TO BOTH ORBITS, FACIAL FRACTURES, AND LACERATIONS TO A HAND AND FOREHEAD, BUT DECLINED SURGERY DUE TO HOSPICE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69396 BED-CHECK MODEL VR MONITOR BED-CHECK KMI STANLEY SECURITY SOLUTIONS, INC. 72031 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UK Other