BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHA RESPONSE

    MDR report key: 5830186 · Received July 28, 2016

    Report

    Report Number
    3005619970-2016-00015
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    June 9, 2016
    Report Date
    August 25, 2016
    Manufacturer
    GETINGE (SUZHOU) CO., LTD.
    Product Code
    FNM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION (E2012066) BY ARJOHUNTLEIGH, INC. (B)(4) ON BEHALF OF THE MANUFACTURER (GETINGE (SUZHOU) CO., LTD.) (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION (E2012066) BY ARJOHUNTLEIGH, INC. (B)(4) ON BEHALF OF THE MANUFACTURER (GETINGE (SUZHOU) CO., LTD.) (B)(4). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. BASED ON THE INFORMATION RECEIVED BY ARJOHUNTLEIGH, ALPHA RESPONSE MATTRESS HAS BOTTOMED OUT WITH A PATIENT ON IT WITH NO LOW PRESSURE ALARM ACTIVATED. THE EVENT OCCURRED DURING TREATMENT, THE PATIENT WAS FOUND ON THE DEFLATED MATTRESS AT 5 O'CLOCK IN THE MORNING. THE PATIENT'S HEALTH CONDITION WAS CHECKED BY THE NURSE AND NO NEGATIVE CONSEQUENCES WERE OBSERVED. REGULAR PATIENT MONITORING RECOMMENDED AS PER THE INSTRUCTION FOR USE PREVENTED FROM A SERIOUS OUTCOME FOR PATIENT - NO INJURY TO THE PATIENT HAS OCCURRED. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND NO OTHER CASES PRESENTING A SIMILAR SCENARIO AS CLAIMED IN THIS COMPLAINT. THEREFORE, THE OCCURRENCE RATE OBSERVED FOR THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE VERY LOW. IT HAS BEEN ESTABLISHED THAT THE ALPHA RESPONSE MATTRESS AND PUMP WERE USED FOR A PATIENT THERAPY AT THE TIME OF THE EVENT AND CONTRIBUTED TO THE OUTCOME OF THE EVENT DUE TO A PCB MALFUNCTION APPLIED BY THE PUMP. BASED ON THE ABOVE, THE PUMP WAS FOUND TO HAVE MALFUNCTIONED (NOT PERFORMING TO SPECIFICATION) WHEN THE EVENT TOOK PLACE. UPON THE VISIT OF THE TECHNICIAN, IT WAS POSSIBLE TO ESTABLISH THAT A DEFECTIVE PCB ON THE PUMP WAS THE MOST LIKELY CAUSE OF AN ALARM LAUNCHING FAILURE. THE PUMP WAS TESTED - THE ALARM WAS WORKING PROPERLY WHEN THE PUMP WAS CONNECTED TO THE MAINS POWER SUPPLY, HOWEVER, IT FAILED TO ACTIVATE WHEN THE DEVICE WAS UNPLUGGED. AS THE PCB BATTERY WAS CONFIRMED TO HAVE BEEN FUNCTIONAL, IT TRACED TO A DEFECTIVE PCB BOARD BEING THE SOURCE OF REPORTED FAILURE. MODEL AND SERIAL NUMBERS OF THE PUMP INVOLVED IN THE EVENT WERE NOT AVAILABLE - UNFORTUNATELY THEY WERE NOT REGISTERED BY THE SERVICE TECHNICIAN DURING THE VISIT. DESPITE OUT BEST EFFORTS, THE CUSTOMER WAS NOT LIKELY TO COOPERATE FURTHER, THE IDF FORM WAS PERCEIVED AS INTRUSIVE AND THE CUSTOMER REFUSED TO HAVE THE DEVICE REPAIRED (FINANCIAL ISSUES). DUE TO THE CUSTOMER'S REACTION, NO ADDITIONAL INFORMATION WAS COLLECTED, THEREFORE, THE MANUFACTURING DATE AND A SERVICE HISTORY OF THE PUMP COULD NOT HAVE BEEN DETERMINED. CONSEQUENTLY, IT WAS NOT POSSIBLE TO CONFIRM THE POTENTIALLY LIKELY SCENARIO OF PCB FAILURE NOR EXAMINE THE COMPONENT FURTHER. THE ROOT CAUSE OF CLAIMED FAILURE CANNOT BE ESTABLISHED DUE TO THE LIMITED INFORMATION RECEIVED. ARJOHUNTLEIGH STRONGLY SUGGESTS TO WITHDRAW THE DEVICE FROM USE UNTIL THE PUMP IS REPAIRED AND FULLY FUNCTIONAL IN ORDER TO PREVENT FROM THE RECURRENCE OF SIMILAR EVENTS. ALTHOUGH NO SERIOUS INJURY TOOK PLACE, WE ARE REPORTING THIS EVENT TO COMPETENT AUTHORITIES IN ABUNDANCE OF CAUTION, DUE TO A PROBABILITY OF HARM WITH A HIGH SEVERITY.

    Description of Event or Problem · 0

    ON (B)(6) 2016 ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT A PATIENT WAS FOUND ON THE DEFLATED ALPHA RESPONSE MATTRESS. IT WAS INDICATED THAT THERE WAS NO ALARM FROM THE ALPHA RESPONSE PUMP TO ALERT CAREGIVERS. THE PATIENT DID NOT PRESENT ANY CONSEQUENCES, THE PATIENT'S SKIN WAS CHECKED AND THE STAFF CHANGED HIS POSITION. THE VISIT AT THE CUSTOMER SITE WAS PERFORMED TO INSPECT THE SYSTEM. IT WAS NOTICED THAT LOW PRESSURE ALARM WAS WORKING DURING THE TEST BUT ALARM THAT SHOULD RING WHEN THE PUMP IS UNPLUGGED DID NOT WORK DUE TO DEFECTIVE PCB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481464 ALPHA RESPONSE ALPHA RESPONSE FNM GETINGE (SUZHOU) CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other