BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU S.P.U.R.

    MDR report key: 498818 · Received November 16, 2003

    Report

    Report Number
    MW1030246
    Event Type
    Malfunction
    Date Received
    November 16, 2003
    Report Date
    November 16, 2003
    Manufacturer
    AMBU INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 1/22/04: SAFETY ANALYSIS - REPORTED POTENTIAL PROBLEM 1: AMBU A/S COMMENT TO REPORTED POTENTIAL PROBLEM 1): THE PRODUCT IS DESIGNED WITH A CAPABILITY OF BEING STORED IN A COMPRESSED STATE (CF. "TELESCOPED") FOR USER CONVENIENCE REGARDING SPACE SAVING. FURTHER THE DESIGN OF THE PRODUCT, E.G. THE FIXATION OF THE RESERVOIR BAG HOUSING IS INTENDED TO WITHSTAND THE FORCE REQUIRED BY THE USER TO EXPAND THE PRODUCT FROM ITS COMPRESSED STATE BEFORE USE, WITHOUT DISASSEMBLING. IF A PRODUCT SHOULD UNINTENTIALLY DISASSEMBLE, CO WOULD REGARD THIS EITHER BEING DUE TO A MANUFACTURING FAULT OR BEING CAUSED BY ERRONEOUS HANDLING DURING USE. RISK EVALUATION OF REPORTED POTENTIAL PROBLEM 1): A) DISASSEMBLY OF THE RESERVOIR DUE TO MANUFACTURING FAULT OR FORESEABLE MISUSE: MFR HAS INVESTIGATED SIMILAR PRODUCTS IN STOCK AT AMBU A/S. CO TESTED THE FORCE NEEDED TO EXPAND THE PRODUCT FROM COMPRESSED ("TELESCOPED") STATE VS THE FORCE NEEDED TO DISASSEMBLE THE RESERVOIR PART OF THE RESUSCITATOR FROM THE TAIL END OF THE BAG. THE RESULT WAS, THAT THE FORCE NECESSARY TO DISASSEMBLE THE PRODUCT WAS IN ALL CASES EVALUATED TO BE FAR IN EXCESS OF THE FORCE REQUIRED TO PULL THE BAG TO EXPANDED STATE. CO BELIEVES THIS RESULT CONFIRMED THE DESIGN OF THE PRODUCT IS ADEQUATE FOR THE INTENDED USE. CO IS NOT ABLE TO INVESTIGATE THE PRODUCTS INVOLVED IN THE REPORTED SITUATION FOR ANY FAULTS IN MATERIALS OR MANUFACTURING. INSTEAD MFR HAS REVIEWED ALL FILED COMPLAINTS FROM 1 JANUARY, 2000 UNTILL TODAY. DURING THIS PERIOD OF TIME SEVERAL HUNDRED THOUSANDS OF PRODUCTS HAS BEEN DELIVERED TO THE USA MARKET. MFR DID FILE ONE COMPLAINT IN 2001 WHERE DETACHMENT OF THE RESERVOIR BAG WAS REPORTED. THE EVALUATION OF THIS COMPLAINT HOWEVER CONCLUDED THERE WAS NO FAULT WITH THE PRODUCT. THE MATERIAL HAD BEEN TORN. CO'S CONCLUSION IS THE ACTUAL RISK OF UNINTENTIONALLY DISASSEMBLING OF THE RESERVOIR DUE TO EITHER A MANUFACTURING FAULT OR FORESEEABLE MISUSE IS ACCEPTABLY LOW. PROBLEM 2: AMBU A/S COMMENT TO REPORTED POTENTIAL PROBLEM 2): THE PRODUCTS HAVE BEEN DESIGNED WITH A MANUALLY ENGAGEABLE OVERRIDE MECHANISM TO ENABLE THE USER TO OVERRIDE THE OVERPRESSURE RELIEF VALVE FROM OPENING, IN CASE THE USER DECIDES TO APPLY HIGH VENTILATION PRESSURE. THIS OVERRIDE MECHANISM IS A SMALL HINGED BAR WITH A CLICK LOCK. THE USER CAN ENGAGE IT BY PRESSING A FINGER FIRMLY ON THE BAR UNTIL THE LOCK IS ENGAGED. THIS FEATURE ENABLES THE USER TO KEEP THE OVERRIDE ENGAGED WITHOUT THE NEED OF CONTINUOUSLY KEEPING HIS OR HER FINGER PRESSED AGAINST THE PRESSURE RELIEF VALVE TO KEEP IT FROM RELIEVING THE OVERPRESSURE. WHEN THE PRODUCT IS PACKAGED THE OVERRIDE BAR IS DISENGAGED. WHEN THE OVERRIDE BAR IS ENGAGED THIS SITUATION IS VISUALLY INDICATED TO THE USER BY A WARNING TRIANGE ON THE OVERRIDE BAR, WHICH IS ONLY VISIBLE WHEN ENGAGED. THE OPERATION AND PRECAUTIONS REGARDING THE OVERRIDE MECHANISM IS DESCRIBED IN THE DIRECTIONS FOR USE. RISK EVALUATION OF REPORTED POTENTIAL PROBLEM 2): CO HAS INSPECTED PACKAGED PRODUCTS FORM CO'S STOCK. THIS INVESTIGATION CONFIRMED THE OVERRIDE MECHANISM WAS NOT ENGAGED IN THE INSPECTED PRODUCTS. MFR HAS REVIEWED THE COMPLAINT FILE FROM 1 JANUARY 2000 UNTILL TODAY. DURING THIS PERIOD OF TIME THOUSANDS OF THE PRODUCTS IN QUESTION HAS BEEN DELIVERED TO THE USA MARKET. CO DID FILE ONE COMPLAINT IN 2000 WHERE THE OVERRIDE MECHANISM WAS REPORTED BEING ENGAGED AS DELIVERED BY AMBU A/S. IT WAS CONCLUDED THIS MIGHT HAVE BEEN CAUSED BY A PACKAGING ERROR. CO'S CONCLUSION IS THE RISK OF UNINTENTIONALLY OVERRIDING OF THE PRESSURELIMITING VALVE DUE TO EITHER A MANUFACTURING FAULT OR FORESEEABLE MISUSE IS ACCEPTABLY LOW.

    Description of Event or Problem · 1

    THE AMBU SPUR SINGLE PT USE RESUSCITATOR BAG IS AN EXCELLENT PRODUCT THAT FUNCTIONS WELL IN THE USE FOR WHICH IT'S INTENDED. REPORTER WISHES TO CALL ATTENTION TO 2 POTENTIAL PROBLEMS RELATED TO HOW THE PRODUCT IS PACKAGED. IN THE CASE OF THE ADULT SIZE AND THE INFANT/CHILD SIZE, THE BAG IS PACKAGED WITH THE INTAKE VALVE "TELESCOPED" INTO THE "TAIL" AREA OF THE BAG, AND SOME FORCE IS REQUIRED TO PULL THE ASSEMBLY OUT OF THIS CONFIGURATION FOR USE. IT IS POSSIBLE TO EXERT SUCH FORCE THAT THE SHROUD CONNECTING THE RESERVOIR BAG TO THE INTAKE VALVE HOUSING IS DISCONNECTED, EITHER FULLY OR PARTIALLY. THIS MUST BE CORRECTED BEFORE THE BAG CAN BE USED. IF IT IS UNDETECTED, IT COULD RESULT IN A LOWER-THAN-INTENDED OXYGEN CONNCENTRATION BEING DELIVERED TO THE PT. ALSO, THIS EXTRA STEP MUST BE COMPLETED IN A HURRY IN WHAT IS OFTEN A STRESSFUL SITUATION OF CARDIO-RESPIRATORY ARREST. THIS DETRACTS FROM THE USABILITY OF AN OTHERWISE FINE DESIGN. REPORTER STRESSES THAT THIS, AS WELL AS THE OTHER PROBLEM REPORTER WILL DESCRIBE, IS NOT A DESIGN OR MANUFACTURING PROBLEM BUT A PACKAGING PROBLEM. THE SECOND PROBLEM PERTAINS ONLY TO THE INFANT/CHILD AND NEONATE SIZE MODELS. IN EACH OF THESE, THERE IS A "POP-OFF" VALVE WHICH IS CONVENTIONALLY USED TO LIMIT THE DELIVERED PRESSURE IN ORDER TO PREVENT BAROTRAUMA TO THE PEDIATRIC LUNG. SOMETIMES THIS PRESSURE MUST BE EXCEEDED WHEN, IN THE OPINION OF THE PROVIDER, THE BENEFIT OF THE HIGHER PRESSURES OUTWEIGHS THE RISK OF BAROTRAUMA IN A PARTICULAR PT. IN THAT INSTANCE, THE "POP-OFF" OR PRESSURE-LIMITING VALVE MAY BE DEFEATED BY APPLYING A HINGED BAR OVER THE OPENING OF THE VALVE, THUS PREVENTING THE BAG FROM "POPPING OFF". THIS IS ADMIRABLE, BUT THE DANGER LIES IN THE FACT THAT THE BAGS ARE PACKAGED WITH THE "POP-OFF" VALVE DEFEATED, OR CONFIGURED IN SUCH A WAY THAT THE BAG BY DEFAULT HAS THE CAPABILITY OF DELIVERING A HIGH PRESSURE. IN SOME PTS THIS MAY BE DELETERIOUS. IT WOULD BE PREFERABLE FOR THE BAG TO BE PACKAGED WITH THE "POP-OFF" VALVE FUNCTIONAL, I.E. SUCH THAT IT WOULD TAKE A SEPARATE DELIBERATE ACTION TO DEFEAT THE SAFETY DEVICE. THERE IS A "MANUAL OVERRIDE" CAPABILITY IN THIS AND OTHER BAGS WHICH IS PREFERABLE TO A "SET AND FORGET" DEVICE WHICH DEFEATS THE SAFETY VALVE. IN THAT INSTANCE, IT IS NECESSARY TO MANUALLY HOLD THE "POP-OFF" OR PRESSURE RELIEF DEVICE CLOSED IN ORDER TO DELIVER A HIGH PRESSURE. THAT CONFIGURATION ALSO "FAILS SAFE", I.E. WITHOUT THE DELIBERATE AND CONTINUOUS ACTION BY THE OPERATOR, IT DEFAULTS TO A CONDITION WHERE THE INSPIRATORY PRESSURE IS LIMITED. THIS WOULD BE PREFERABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU S.P.U.R. PORTABLE, DISPOSABLE MANUAL RESUSCITATOR BTM AMBU INC. 430-213-000 *
    2 AMBU S.P.U.R. PORTABLE, DISPOSABLE MANUAL RESUSCITATOR BTM AMBU INC. 444-4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *