BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL MEDICAL PRODUCTS

    MDR report key: 2114324 · Received May 2, 2011

    Report

    Report Number
    1929691-2011-00002
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CLAIMS THAT THE UMP MONITOR, SUSPECT MODEL #91070, WORKED BEFORE AND AFTER THE INCIDENT. NOT ENOUGH INFORMATION CAN BE DRAWN FROM THE ALLEGED INCIDENT AS THE UMP MONITOR INVOLVED IN THE INCIDENT CAN NOT BE LOCATED BY THE CUSTOMER AND THEREFORE CAN NOT BE EVALUATED BY THE MANUFACTURER. DURING A FACILITY VISIT MADE BY THE MANUFACTURER'S STAFF ON (B)(4) 2011, (B)(6) ASKED QUESTIONS ABOUT THE MAT BEING PINCHED BY THE BED, AS THE HEAD OF THE RESIDENT'S BED HAD BEEN RAISED THE HEAD A 30 TO 40 DEGREE ANGLE, PRIOR TO THE RESIDENT EXITING THE BED. PURSUANT TO THE SITE VISIT, A CAPA WAS RAISED AND (B)(4) TESTED THIS HYPOTHESIS. THEY WERE NOT ABLE TO PRODUCE A NO ALARM CONDITION. HOWEVER, IT WAS CONFIRMED THAT IT WAS POSSIBLE TO DEFEAT THE SYSTEM IF THE CORD TO THE AIR MATTRESS IS PINCHED. USER INSTRUCTIONS ALREADY IDENTIFY THIS POTENTIAL CONDITION AND WARN AGAINST SUCH ACTION BY THE END USER. AS STATED BY FACILITY STAFF, THE UNIT INVOLVED IN THE INCIDENT WAS PROPERLY FUNCTIONING PRIOR TO AND AFTER THE PATIENT'S INJURY HAD OCCURRED AND HAS BEEN MOST LIKELY BEEN PLACED BACK IN USE BY THE END USER.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE (B)(6) REPORTED THAT A RESIDENT FELL ON (B)(6) 2011 AND HAD SUSTAINED A BROKEN LEG AND A SMALL LACERATION ABOVE THE RIGHT EYE AFTER EXITING THE BED. STAFF MEMBERS CLAIM THAT THE UNIT WAS OPERATING AS IT SHOULD BEFORE THE INCIDENT AND THAT THE RESIDENT WAS ONLY LEFT UNATTENDED FOR 4 TO 5 MINUTES. THE RESIDENTS ROOM IS LOCATED NEAR THE NURSE'S STATION AND STAFF WAS ABLE TO HEAR HER AND COME TO HER AID. SEVERAL STAFF MEMBERS TESTED THE MONITOR IMMEDIATELY AFTERWARDS AND INDICATED THAT IT WAS WORKING PERFECTLY. FACILITY ORIGINALLY REPORTED THAT THE BS-5 UNIT WAS TOSSED IN THE TRASH ON (B)(6)2011, BUT LATER STATED THAT IT IS LIKELY TO STILL BE IN SERVICE. HOWEVER, THEY DO NOT KNOW SPECIFICALLY WHICH RESIDENT IT MAY BE MONITORING. IT WAS REPORTED THAT THE AIR MATTRESS FOR THE BS-5 UNIT WAS TOSSED IN THE TRASH ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL MEDICAL PRODUCTS UMP BS-5 KMI STANLEY SECURITY SOLUTIONS, INC. SUSPECT 91070/BS-5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1