BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SEMIAUTOMATIC DEFIBRILLATOR

    MDR report key: 34238 · Received July 18, 1996

    Report

    Report Number
    MW1009513
    Event Type
    Malfunction
    Date Received
    July 18, 1996
    Date of Event
    July 14, 1996
    Report Date
    July 17, 1996
    Manufacturer
    LAERDAL MEDICAL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    SEMIAUTOMATIC DEFIBRILLATOR FAILED TO ASSESS ELECTRICAL ACTIVITY OR TO CHARGE IN ORDER TO DELIVER A DEFIBRILLATORY PULSE. THE CAUSE OF THIS APPEARS TO BE A FAILURE WITHIN THE TAPE DRIVE MECHANISM TO DETECT THAT THE TAPE DOOR IS CLOSED. THE TAPE DOOR CLOSURE IS REQUIRED IN ORDER FOR THE DEFIBRILLATOR TO ASSESS OR CHARGE. APPROX ONE MONTH AGO, THE UNIT EXPERIENCED A SINGLE OCCURRENCE WHERE THE TAPE DRIVE SYSTEM FAILED TO RETRACT FROM THE TAPE CASSETTE PREVENTING REMOVAL OF THE CASSETTE. THE TAPE DOOR WAS CYCLED ONCE OR TWICE AND THE TAPE DRIVE SYSTEM RETRACTED AND THE CASSETTE WAS REMOVED. NO ADD'L ACTION WAS TAKEN. ON 7/14, DURING A TRAINING SESSION, THE SAD WAS ACTIVATED WITH A PT SIMULATOR ATTACHED. FOLLOWING ACTIVATION A "CLOSE TAPE DOOR" MESSAGE WAS RECEIVED. THE TAPE DOOR WAS CYCLED OPEN THEN CLOSED AND THE SAD WAS REACTIVATED. AN "ASSESSING - HAND OFF" MESSAGE WAS ANNUNCIATED FOLLOWED BY A "CHECK TAPE" MESSAGE. THE UNIT WAS POWERED OFF AND THE TAPE DOOR WAS OPENED AND THE TAPE WAS CHECKED. THE TAPE DRIVE MECHANISM HAD JAMMED SUCH THAT WHEN THE DOOR WAS OPENED THE CASSETTE COULD NOT BE REMOVED. THE DOOR WAS CYCLED SEVERAL TIMES IN AN ATTEMPT TO CAUSE THE MECHANISM TO RETRACT. NO RETRACTION OF THE MECHANISM OCCURRED AND THE DOOR WAS CLOSED. THE UNIT WAS REPOWERED AND AN ATTEMPT WAS MADE TO ASSESS. AT THIS TIME THE UNIT REPEATEDLY ANNOUNCED "CLOSE TAPE DOOR" AND WOULD NOT ASSESS THE SIMULATED PT OR CHARGE FOR DEFIBRILLATION. MFR WAS CONTACTED REGARDING THIS INCIDENT AND THEY ADVISED THAT THEY HAD AN ENGINEERING CHANGE TO THE TAPE DRIVE UNIT THAT WAS BEING PERFORMED AS UNITS WERE RETURNED TO THE MFR FOR OTHER REASONS. THIS CHANGE WAS TO REPLACE CERTAIN BELT(S), SPRING(S), AND PULLEY(S) ACCORDING TO THEIR TECHNICIAN. RPTR WAS ADVISED BY THE REPAIR SUPERVISOR THAT THE FAILURE RPTR HAD SEEN COULD NOT BE RELATED TO THE USERS THAT THE UNITS HAD BEEN DETERMINED TO NEED MODIFICATIONS TO THE TAPE DRIVE. THEIR COMMENTS WERE THAT THIS WOULD BE PICKED UP ON A ROUTINE FACTORY PERFORMED PREVENTIVE MAINTENANCE CHECK. CO LITERATURE, HOWEVER, DOES NOT RECOMMEND A ROUTINE FACTORY PREVENTIVE MAINTENANCE EXAMINATION OF THESE UNITS. BASED UPON THE INFO AVAILABLE RPTR'S INTERNAL CHECKS OF OPERATION AND UNIT INTEGRITY WERE ALL THAT WERE FELT TO BE REQUIRED. EVEN THOUGH RPTR WAS AWARE THAT THE TAPE DRIVE MECHANISM WAS A PORTION OF THE SENSOR SYSTEM TO ALLOW ASSESSMENT AND DEFIBRILLATION OPERATIONS TO OCCUR, IT NEVER OCCURRED TO USER THAT A SIMPLE FAILURE TO DETECT THE TAPE DOOR BEING CLOSED WOULD PREVENT OPERATIONS. THIS INHIBITION APPEARS TO SERVE NO OBVIOUS FUNCTION TO PROTECT EITHER THE PT OR THE OPERATOR. IT SHOULD BE REMOVED FROM THE UNITS AS SOON AS POSSIBLE IN ORDER TO ENSURE THAT NO FAILURES OF THIS TYPE WILL OCCUR DURING PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SEMIAUTOMATIC DEFIBRILLATOR SEMIAUTOMATIC DEFIBRILLATOR MKJ LAERDAL MEDICAL CORP. 1000S

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO