BEUDAMED
    FDA Adverse Event Other Summary report: N

    DFS2

    MDR report key: 2935851 · Received January 22, 2013

    Report

    Report Number
    1000381138-2013-00001
    Event Type
    Other
    Date Received
    January 22, 2013
    Report Date
    December 27, 2012
    Manufacturer
    ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB
    Product Code
    FNM
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH INC ON BEHALF OF THE MFR (ARJO LTD (B)(4)). IT WAS FOUND DURING A REPAIR OF OUR DFS2 MATTRESS SYSTEM THAT THE PT HAD SMOKED IN HIS BED AND SEVERAL CIGARETTES HAD BURNED HOLES IN THE MATTRESS AND THE REMAINING PART OF THE CIGARETTE HAD COME TO REST INSIDE THE COVER OF THE MATTRESS BETWEEN THE AIR CELLS. THERE HAS BEEN NO REPORTED INJURIES FROM THIS CUSTOMER AND IT WAS FELT THAT WE (ARJOHUNTLEIGH) DEEMED THIS SERIOUS ENOUGH TO REPORT BASED ON THE POTENTIAL FOR SERIOUS INJURY, ALBEIT NOT AS A RESULT OF ANY MALFUNCTION OF OUR SYSTEM. WE CONCLUDE THAT THIS FAILURE IS AS A RESULT OF THE PT FAILING TO TAKE THE NECESSARY SAFETY PRECAUTIONS WHEN USING OUR PRODUCT. IT SEEMS THAT WARNINGS HAVE PREVIOUSLY BEEN GIVEN TO THIS PT BY THE RENTAL SUPERVISOR AND ALSO LISTED IN OUR IFU TO NO AVAIL. WE HAVE AGAIN INFORMED THE PT THAT HIS ACTIONS ARE PLACING HIM AND OTHERS AT RISK. WE HAVE REVIEWED OUR POST MARKET SURVEILLANCE DATA AND FOUND DURING THE LAST 5 YRS THAT WE HAVE REPORTED THREE SIMILAR EVENTS WHEREBY THE PT/USER HAS SMOKED IN BED CAUSING A FIRE, HOWEVER IN THIS INSTANCE THERE WAS NO INVOLVEMENT OF A FIRE OR ANY INJURY TO THE PT. THE THREE SIMILAR EVENTS ARE: 2011 - MDR# 1000381138-2011-00031; 2012 - MDR# - 3007420694-2012-00025; 2012 - MDR# - 3007420694-2012-00062. THE RISK ANALYSIS OF THE NIMBUS SYSTEM DOES COVER FIRE RISK BY SMOKING (HM151 - 152 NIMBUS SYSTEM ISS1). THE RISK IS FOUND TO HAVE A HIGH SEVERITY LEVEL AND A LOW FREQUENCY OF OCCURRENCE. WITH THE HIGH RISK OF SERIOUS INJURY, THIS EVENT IS CONSIDERED TO BE REPORTABLE TO THE COMPETENT AUTHORITIES.

    Description of Event or Problem · 1

    PER THE AHUS RENTAL SUPERVISOR'S COMMENTS: "PT HAD A LOANER DFS2 SYSTEM WHILE HIS BED WAS BEING REPAIRED. UPON ITS RETURN TO THE HOUSTON DEPOT THE PT HAD SMOKED IN HIS BED AND THAT SEVERAL CIGARETTES HAD BURNED A HOLE IN THE MATTRESS AND CAME TO REST INSIDE OF THE COVER ON THE AIR CELLS." THIS IS A HOME CARE PT FROM THE (B)(6) FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31496 DFS2 NONE FNM ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB 152003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other