BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE 8000

    MDR report key: 3080670 · Received April 8, 2013

    Report

    Report Number
    3007420694-2013-00016
    Event Type
    Injury
    Date Received
    April 8, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FNL
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MANUFACTURER ARJOHUNTLEIGH (B)(4). THE DEPUTY DIRECTOR OF NURSING AND MIDWIFERY AT (B)(6) HOSPITAL HAS ADVISED THAT THE BED INVOLVED IN THE INCIDENT HAS BEEN PUT BACK INTO SERVICE AND THEY ARE UNABLE TO PROVIDE THE SERIAL NUMBER, THEY HAVE ALSO STATED THAT THE BED WAS AN ENTERPRISE 8000 MODEL WHICH WAS IN GOOD CONDITION. FOLLOWING ON FROM THEIR INITIAL DESCRIPTION OF THE INCIDENT, FURTHER DETAILS ABOUT THE INCIDENT WERE REQUESTED; THE HOSPITALS DEPUTY DIRECTOR OF NURSING AND MIDWIFERY ADVISED THAT TWO STAFF MEMBERS WERE MANOEUVRING THE BED AND THE INJURY OCCURRED WHILST THE STAFF MEMBER WAS MANOEUVRING THE BED IN A TIGHT UNIT. IT IS BELIEVED THE INJURED STAFF MEMBER WAS STEERING THE BED AND ATTEMPTING TO AID ITS CHANGE IN DIRECTION WHILST THE BED WAS ALSO BEING PUSHED FROM BEHIND. ALSO THE INJURY TO THE STAFF MEMBER'S LEG WAS TO THE BACK OF THE CALF. THEREFORE, AS THE INJURY TO THE STAFF MEMBER'S LEG WAS TO THE BACK OF THE CALF, THIS IS CONSISTENT WITH THE STAFF MEMBER BEING IN FRONT OF THE BED PULLING IT BEHIND THEM, WHILST AT THE SAME TIME THE BED WAS BEING PUSHED FROM BEHIND. AS A CONSEQUENCE OF THIS THE BED HAS CAUGHT THE BACK OF THEIR CALF AS IT RAN INTO THEM, AND THE RELATIVE HEIGHT OF INJURY SITE IS CONSISTENT WITH THE BOTTOM EDGE OF CABLE TIDY BRACKET WHICH IS 300MM FROM THE FLOOR. ALTHOUGH WE HAVE NOT BEEN ABLE TO REVIEW THE ACTUAL BED, IT IS UNLIKELY THAT THERE ARE ANY ISSUES WITH THE BED RELATED TO THIS INCIDENT AS THE HOSPITAL HAS PUT THE BED BACK INTO SERVICE. IN SUMMARY, THE DEVICE WAS BEING USED AT THE TIME OF THE EVENT AS IT WAS BEING MOVED BETWEEN LOCATIONS AND CONTRIBUTED TO THE OUTCOME OF THE EVENT: INJURING THE STAFF MEMBERS ON THE BACK OF THE CALF, THERE WAS NO FAILURE OF THE DEVICE SO IT HAS MET ITS SPECIFICATIONS. WE HAVE REVIEWED OUR POST MARKET SURVEILLANCE FOR SIMILAR EVENTS AND WE DO NOT HAVE ANY RECORDED INCIDENTS OF THIS NATURE OUT OF APPROXIMATELY (B)(4) BEDS SOLD SINCE THE ENTERPRISE WAS FIRST PLACED ONTO THE MARKET IN 2006. GIVEN THE CIRCUMSTANCES AND THE NUMBER OF PRODUCTS IN THE MARKET, THIS INCIDENT APPEARS TO BE ISOLATED ISSUE. WE DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144244 ENTERPRISE 8000 MEDICAL BED FNL ARJOHUNTLEIGH POLSKA SP. ZO.O.

    Patients

    Seq Age Sex Outcome Treatment
    1