BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 2000

    MDR report key: 3964765 · Received June 25, 2014

    Report

    Report Number
    9611530-2014-00041
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILM
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR SYSTEM 2000 WE HAVEN'T' FOUND ANY OTHER SIMILAR CASES. WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS NO COMPLAINT TREND CONCERNING THESE KIND OF EVENTS - SMOKE FROM THE UNIT. PLEASE NOTE THAT ARJOHUNTLEIGH MANUFACTURED OVER (B)(4) SYSTEM 2000 BATHS TO DATE. THE DEVICE WAS INSPECTED BY AN ARJOHUNTLEIGH REPRESENTATIVE AT THE CUSTOMER SITE AND FOUND TO BE OUT OF THE SPECIFICATION. THE DEVICE WAS BEING USED FOR PATIENT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. NO INJURY TO THE PATIENT OCCURRED - PATIENT WAS OBSERVED OVERNIGHT AND TAKEN TO THE DOCTOR NEXT DAY BUT NO LASTING EFFECTS. INSTRUCTION FOR USE (IFU) IS ATTACHED WITH EACH DEVICE. REC'D INFO SHOWED THAT THE PATIENT WAS LEFT ALONE WHEN THE EVENT OCCURRED, AND HE NOTICED SMOKE COMING FROM THE DEVICE WHEN HE ENTERED THE ROOM. AFTER THAT, HE HELPED THE PATIENT GET OUT OF THE TUB. OUR INVESTIGATION SHOWS THAT ALTHOUGH THERE WAS SMOKE FROM A FAILING CAPACITOR, THERE HAS BEEN NO FIRE NOR FIRE RISK. IF DURING PREVENTIVE MAINTENANCE SOME PARTS WOULD HAVE BEEN FOUND DAMAGED OR DEFECTIVE, ESPECIALLY PARTS THAT ARE ESSENTIAL FOR SAFETY, THEY SHOULD BE REPLACED OR REPAIRED. IN THAT CASE DEVICE SHOULDN'T BE USED BECAUSE SAFETY OF THE PRODUCT IS NEGLECTED. WE WERE NOT ABLE TO ESTABLISH THE EXACT ROOT CAUSE OF REPORTED MALFUNCTION. WE CAN CONSIDER THAT THIS PROBLEM COULD BE RELATED TO POOR MAINTENANCE AS NO INFO OF LAST SERVICE WAS PROVIDED AND SIGNS OF WEAR OF HYDROMASSAGE PUMP ARE VISIBLE. IT CAN BE ALSO STATED THAT WHEN THE EVENT OCCURRED, CAREGIVER NOT FOLLOWED RECOMMENDATION FROM INSTRUCTION FOR USE REGARDING SUPERVISION OF THE PATIENT DURING USE. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370519 SYSTEM 2000 ILM ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1