BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 5000

    MDR report key: 6221013 · Received January 4, 2017

    Report

    Report Number
    3007420694-2017-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2017
    Date of Event
    September 27, 2016
    Report Date
    February 2, 2017
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP Z O.O
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP.Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). COMMENT ON PATIENT CODES: 2199 - PATIENT DID NOT SUSTAIN ANY INJURY. 1994 - NURSING ASSISTANT OVERREACHED AND SUSTAINED BACK STRAIN AND THIS ASSISTANT FELT PAIN IN IT. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP.Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ON 2016-DEC-12 ARJOHUNTLEIGH RECEIVED A COMPLAINT WHERE IT WAS STATED THAT CABLE ON ENTEPRISE5000 PATIENT HANDSET IS STRETCHED AND SITS ON FLOOR CAUSING A TRIPPING HAZARD. PATIENT HANDSET CABLE HAS EXPANDED OVER TIME. SO WHEN STORED ON SAFETY RAILS IT SITS ON THE FLOOR. THE INVESTIGATION REPORT PERFORMED BY NHS TRUST REVEALED THAT PATIENT STOOD INDEPENDENTLY BUT APPEARED TO HAVE FOOT STUCK FAST IN BED CONTROLS. NURSING ASSISTANT REPORTS THAT HE WENT TO PATIENT'S ASSISTANCE, PATIENT TRIPPED, FALLING BACKWARDS, PUSHING THE NURSING ASSISTANT AWAY FROM HIM. PATIENT CAME TO REST SITTING ON BED BUT NURSING ASSISTANT OVERREACHED. NURSING ASSISTANT CONTINUED HIS SHIFT BUT STATES THAT EVENTUALLY DUE TO PAIN AND INJURY ATTENDED URGENT CARE. ACCORDING TO THE URGENT CARE CENTRE SLIP, NA1 WAS ADVISED LIGHT DUTIES. THE BACK STRAIN THE CAREGIVER SUSTAINED AS REPORTED IN THIS EVENT DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY AS DEFINED IN 21 CFR 803.3 NO TREND FOR THE PROBLEM UNDER THIS INVESTIGATION IS OBSERVED. IN THE INSTRUCTIONS FOR USE (746-445-6.1-UK) THERE IS INFORMATION ON CARE AND PREVENTIVE MAINTENANCE (PLEASE REFER TO PAGE 34) STATING THAT - CHECK PATIENT HANDSET AND CABLE ON WEEKLY BASIS. PREVENTIVE MAINTENANCE CAN HELP TO PREVENT ACCIDENTS OF THIS KIND. WHAT IS MORE - ON YEARLY BASIS THE USER SHALL EXAMINE ALL ACCESSIBLE FLEXIBLE CABLES FOR DAMAGE AND DETERIORATION. DUE TO THE FACT THAT THE CABLE WAS EXTENDED WE CAN CONCLUDE THAT THIS ITEM WAS IN USE FOR A VERY LONG TIME. ARJOHUNTLEIGH WAS NOT ABLE TO GATHER INFORMATION ON THE SERVICING COMAPNY OF THE DEVICE OR THE SERVICE RECORDS. WHAT IS MORE, THE SERIAL NUMBER WAS NOT TRACEABLE THUS NO SERVICE OR DESIGN HISTORY RECORDS FOR THIS DEVICE WERE FOUND. WE DEEM THAT THE CAUSE OF THIS COMPLAINT IS USE ERROR - IMPROPER MAINTENANCE OF THE DEVICE DUE TO THE FACT THAT SUCH CABLE DETERIORATION SHALL BE DISCOVERED AND AN ARJOHUNTLEIGH OR AN APPROVED SERVICE AGENT SHALL BE CONTACTED IMMEDIATELY. IN SUMMARY, THE DEVICE WAS BEING USED WITH THE PATIENT AT THE TIME OF EVENT AND THE FAILURE IS CONSIDERED AS A TECHNICAL MALFUNCTION OF THE DEVICE AND USER ERROR CONTRIBUTED TO THAT EVENT. DESPITE THAT THE EVENT DID NOT RESULT IN ANY SERIOUS INJURY TO PATIENT OR CAREGIVER, THE COMPLAINT IS CONSIDERED REPORTABLE SINCE SUCH SITUATION MIGHT POSSIBLY POSSIBLE POSE A RISK TO THE PATIENT'S HEALTH IF IT WAS TO RECCUR AND CAREGIVER WAS NOT PRESENT TO PREVENT THE PATIENT FROM FALLING.

    Description of Event or Problem · 0

    ON (B)(6) 2016 ARJOHUNTLEIGH RECEIVED A COMPLAINT WHERE IT WAS STATED THAT CABLE ON ENTEPRISE5000 PATIENT HANDSET IS STRETCHED AND SITS ON FLOOR CAUSING A FALLS RISK. PATIENT HANDSET CABLE HAS EXPANDED OVER TIME. SO WHEN STORED ON SAFETY RAILS IT SITS ON THE FLOOR. THE INVESTIGATION REPORT PERFORMED BY (B)(6) REVEALED THAT PATIENT STOOD INDEPENDENTLY BUT APPEARED TO HAVE FOOT STUCK FAST IN BED CONTROLS. NURSING ASSISTANT REPORTS THAT HE WENT TO PATIENT'S ASSISTANCE, PATIENT TRIPPED, FALLING BACKWARDS, PUSHING THE NURSING ASSISTANT AWAY FROM HIM. PATIENT CAME TO REST SITTING ON BED BUT NURSING ASSISTANT OVERREACHED. NURSING ASSISTANT CONTINUED HIS SHIFT BUT STATES THAT EVENTUALLY DUE TO PAIN AND INJURY ATTENDED URGENT CARE. ACCORDING TO THE URGENT CARE CENTRE SLIP, NA1 WAS ADVISED LIGHT DUTIES. THE BACK STRAIN THE CAREGIVER SUSTAINED AS REPORTED IN THIS EVENT DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY AS DEFINED IN 21 CFR 803.3

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5349 ENTERPRISE 5000 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP Z O.O 5000BA22A12BA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other