BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS 3/ DFS3

    MDR report key: 5015525 · Received August 13, 2015

    Report

    Report Number
    3007420694-2015-00160
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    August 1, 2015
    Report Date
    August 3, 2015
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FNM
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2015 IT WAS REPORTED TO ARJOHUNTLEIGH THAT DURING THE NIGHT FROM SATURDAY TO SUNDAY, THE NIMBUS 3 MATTRESS BURNED IN A PATIENT'S ROOM. THE PATIENT WAS NOT INJURED, THE PATIENT LEFT THE ROOM WHEN THE FIRE STARTED; ARJOHUNTLEIGH MADE SEVERAL ATTEMPTS TO CONTACT THE HOSPITAL TO GET ADDITIONAL INFORMATION ABOUT THE CAUSE OF THE FIRE AND ALL SURROUNDING CIRCUMSTANCES. THE HOSPITAL DID NOT REVEAL ANY DETAILS HOWEVER THEY CONFIRMED THAT OUR DEVICE DID NOT CAUSE OR CONTRIBUTED TO THE FIRE IN THE PATIENT'S ROOM. IN RELATION TO THE RISK OF FIRE, OUR MATTRESS MATERIAL IS FLAME RETARDANT TO BS7175 ((B)(6) STANDARD - FLAME RETARDANT BEDDING FOR BEDCOVERS AND SHEETS ) AND WE ALSO WARN OUR CUSTOMERS (AS PER THE 'GENERAL WARNING' PAGES IN OUR INSTRUCTION FOR USE) OF THE REMAINING FLAMMABILITY RISKS INVOLVED IN USING OUR PRODUCT. THE PRODUCT IFU #(B)(6) CONTAINS THE FOLLOWING: "DO NOT EXPOSE THE SYSTEM, ESPECIALLY THE MATTRESS, TO NAKED FLAMES, SUCH AS CIGARETTES, ETC". WE CONCLUDE THAT THIS FAILURE IS SOLELY A RESULT OF AN EVENT BEYOND THE REALM OF OUR CONTROL. OUR PRODUCT AT THE TIME OF THE EVENT WAS FUNCTIONING AS PER ITS INTENDED USE AND WAS NOT A DIRECT CAUSE OF THE INCIDENT, IT WAS SIMPLY PRESENT AND THE EXISTING RISK MITIGATIONS PERFORMED AS INTENDED. ALTHOUGH NOBODY WAS INJURED AS A RESULT OF THIS EVENT, THE RISK ASSOCIATED TO THIS PARTICULAR INCIDENT IS REGARDED AS SEVERE, THEREFORE WE CONSIDERED TO BE REPORTABLE TO THE COMPETENT AUTHORITIES IN ABUNDANCE OF CAUTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). ARJOHUNTLEIGH HAVE BEEN ABLE TO GATHER LITTLE INFORMATION ABOUT THE EVENT SO FAR. A FIRE HAS STARTED IN A PATIENT'S ROOM (IMPOSSIBLE TO KNOW IF THE PATIENT STARTED IT INTENTIONALLY OR NOT). THE PATIENT LEFT THE ROOM WHEN THE FIRE STARTED; NO INJURY REPORTED. THE FACILITY CALLED THE FIREFIGHTERS AND THE POLICE; THE POLICE IS INVESTIGATING THE EVENT THEREFORE ARJOHUNTLEIGH WAS NOT ALLOWED TO ACCESS THE ROOM AND INSPECT THE DEVICE. ADDITIONAL ATTEMPTS OF CONTACT WILL BE MADE TO GATHER ADDITIONAL INFORMATION. FOLLOW UP REPORT WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2015, IT WAS REPORTED TO ARJOHUNTLEIGH THAT DURING THE NIGHT FROM SATURDAY TO SUNDAY, THE MATTRESS BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532482 NIMBUS 3/ DFS3 FNM ARJOHUNTLEIGH POLSKA SP. ZO.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other