BEUDAMED
    FDA Adverse Event Death Summary report: N

    NIMBUS

    MDR report key: 8163880 · Received December 14, 2018

    Report

    Report Number
    3005619970-2018-00020
    Event Type
    Death
    Date Received
    December 14, 2018
    Date of Event
    November 1, 2018
    Report Date
    January 25, 2019
    Manufacturer
    GETINGE (SUZHOU) CO., LTD.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012066 BY THE GETINGE SUZHOU LTD (REGISTRATION #(B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH INC (AHUS) (REGISTRATION #(B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ARJO WAS NOTIFIED ABOUT AN INCIDENT INVOLVING NIMBUS SYSTEM. THE EXACT MODEL NUMBER AND SERIAL NUMBER WAS NOT PROVIDED. IT WAS REPORTED BY (B)(6) FIRE AND RESCUE SERVICE THAT THERE WAS A FATAL FIRE AND THE DECEASED WAS SLEEPING ON WHAT WAS BELIEVED TO BE A NIMBUS AIR MATTRESS. CURRENTLY, THERE IS NO INDICATION THAT ARJO MATTRESS COULD CONTRIBUTE TO THE ISSUE. INVESTIGATION BY FIRE AND RESCUE SERVICE IS ONGOING.

    Additional Manufacturer Narrative · 1

    ARJO WAS NOTIFIED ABOUT AN INCIDENT INVOLVING NIMBUS SYSTEM. THE EXACT MODEL NUMBER AND SERIAL NUMBER WAS NOT PROVIDED. IT WAS REPORTED BY (B)(6) THAT THERE WAS A FATAL FIRE AND THE PATIENT WAS SLEEPING ON WHAT WAS BELIEVED TO BE A NIMBUS AIR MATTRESS. AS THE FIRE SERVICE DURING INSPECTION NOTICE THAT BRAND NAME "NIMBUS" WAS VISIBLE ON REMAINS OF PUMP. THE EQUIPMENT HAS BEEN ISOLATED. ARJO HAD NO ACCESS TO CONFIRMED ANY DETAILS. CURRENTLY, THERE WAS NO INDICATION THAT ARJO MATTRESS COULD CONTRIBUTE TO THE ISSUE. INVESTIGATION BY FIRE AND RESCUE SERVICE IS ONGOING. NO ADDITIONAL INFORMATION WAS PROVIDED TO THIS DATE. NIMBUS MATTRESSES COMPRISE OF AIR-INFLATED, ALTERNATING PRESSURE CELLS DEDICATED FOR PREVENTION AND MANAGEMENT OF PRESSURE ULCERS. TOP COVERS OF NIMBUS MATTRESSES ARE MADE OF A PU COATED FABRIC WHICH IS FIRE RETARDANT MATERIAL TESTED IN ACCORDANCE WITH APPLICABLE STANDARDS. PLEASE NOTE THAT MATTRESSES BASE COVERS HAS BEEN TESTED ACCORDING TO BS7175 - (B)(4) STANDARD - FLAME RETARDANT BEDDING FOR BEDCOVERS AND SHEETS AND PASSED THIS TEST WITH POSITIVE RESULT. FOLLOWING THE INSTRUCTION FOR USE #151996: "DO NOT EXPOSE THE SYSTEM, ESPECIALLY THE MATTRESS, TO NAKED FLAMES, SUCH AS CIGARETTES, ETC". "IN THE EVENT OF A FIRE, A LEAK IN THE SEAT OR MATTRESS COULD PROPAGATE THE FIRE." FROM ARJO REVIEW IT WAS CONCLUDED THAT THERE THE PRODUCT IS NOT VIOLATIVE IN ANY WAY. THE MATERIAL OF NIMBUS TOP COVER IS CONFORMING TO APPLICABLE STANDARDS AND IS NOT CONSIDERED TO HAVE CONTRIBUTED TO THE OUTCOME OF THIS UNFORTUNATE INCIDENT WHICH WAS REPORTED. TO SUM UP THERE WAS LIMITED INFORMATION RELATED TO EVENT CIRCUMSTANCES. THE NIMBUS SYSTEM PLAYED A ROLE IN THE INCIDENT AS IT IS BELIEVED THAT THE PATIENT WAS SLEEPING ON THE MATTRESS. IF THE INVESTIGATION RESULTS (CONDUCTED BY FIRE AND RESCUE SERVICE) WILL BE SHARED AND GIVE NEW LIGHT INTO THE INVESTIGATION OR ROOT CAUSE, THE FOLLOW UP REPORT WITH NEW CONCLUSION WILL BE SENT TO AUTHORITIES. COMPLAINT DECIDED TO BE REPORTABLE DUE TO A CRITICAL PATIENT'S OUTCOME.

    Additional Manufacturer Narrative · 1

    COLLECTING INFORMATION ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003417 NIMBUS MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM GETINGE (SUZHOU) CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death