BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1173343 · Received September 23, 2008

    Report

    Report Number
    3002158293-2008-00481
    Event Type
    Death
    Date Received
    September 23, 2008
    Date of Event
    August 24, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: MONITOR - 2008; BATTERY PACK - 2007; ELECTRODE BELT - 2008. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF MONITOR, BATTERY PACK AND ELECTRODE BELT HAVE BEEN COMPLETED. THE BATTERY PACK HAD A DAMAGED LOCKING TAB. THE BATTERY PACK WAS REPAIRED. IT WAS RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE DAMAGED CLIP CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO FORCIBLE REMOVAL OF THE BATTERY PACK FROM THE MONITOR WITHOUT PRESSING THE LOCKING TAB BEFORE PULLING. THE MONITOR HAD A BROKEN LCD. IT WAS REPAIRED, RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE BROKEN LCD WAS PROBABLY FROM THE FALL OF THE PATIENT ON THE MONITOR. THE ELECTRODE BELT WAS FULLY FUNCTIONAL. IT WAS REFURBISHED, RETESTED AND RESTOCKED. THE PATIENT DIED BECAUSE NONE OF THE BYSTANDERS KNEW HOW TO ACTIVATE THE DEVICE AFTER BATTERY PACK AND SLID FROM THE MONITOR DURING THE FALL. THE HOLSTER HAD REENGAGED THE BATTERY PACK AFTER THE FALL. ATTACHED IS THE EVENT ANALYSIS FROM MEDICAL AFFAIRS AND THE ECG THE DEVICE RECORDED. CONCLUSION: A MAN WENT INTO VT WHILE WEARING THE LIFE VEST. THE LIFEVEST PROPERLY DETECTED THE ARRHYTHMIA AND STARTED A TREATMENT SEQUENCE. DURING THE TREATMENT SEQUENCE THE PATIENT FELL CAUSING AN IMPACT TO THE LIFE VEST MONITOR OF SUFFICIENT FORCE TO CAUSE MECHANICAL DAMAGE TO THE INTERNAL DISPLAY. WITHIN 5 SECONDS AFTER GEL RELEASE SYSTEM POWER WAS LOST FOR APPROXIMATELY 30 SECONDS AND THEN RESTORED CAUSING A SYSTEM RESTART. WHEN THE DEVICE STARTED UP AGAIN, THE RESPONSE BUTTON TEST, WHICH IS INITIATED EVERY TIME THE DEVICE IS STARTED UP, BEGAN AND THE DEVICE PROMPTED, "TO ACTIVATE DEVICE, PRESS RESPONSE BUTTONS". HOWEVER, THE BYSTANDERS DID NOT KNOW HOW TO ACTIVATE THE RESPONSE BUTTONS. SINCE THE LED DISPLAY WAS CRACKED DURING THE PATIENT'S FALL, THE BYSTANDERS COULD NOT VIEW THE ANIMATION DEMONSTRATING HOW TO USE THE RESPONSE BUTTONS. A NURSE ATTEMPTED CPR UNTIL THE EMS ARRIVED. THE EMS CONTINUED CPR AND ADMINISTERED DRUGS TO THE PATIENT, HOWEVER, THE PATIENT WAS ALREADY IN ASYSTOLE WHEN THEY ATTACHED THEIR MONITOR TO HIM AND THE PATIENT DIED. THE LIFE VEST WORKED AS DESIGNED. THE MONITOR WAS EVALUATED AND WAS FOUND TO HAVE NO DEFICIENCIES OTHER THAN A LOSS OF DISPLAY FUNCTION DUE TO A CRACKED DISPLAY ASSEMBLY.

    Description of Event or Problem · 1

    THE TERRITORY MANAGER (TM) OF A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PATIENT HAD DIED. THE FIRST REPORT THAT THE PATIENT WAS WEARING THE DEVICE AND HAD A VENTRICULAR FIBRILLATION (VF) ARREST AND DIES. TM CALLED BACK THREE HOURS LATER AND TOLD SUPPORT THAT THE PATIENT HAD COLLAPSED AT WORK. THE EMERGENCY MEDICAL SERVICE (EMS) REMOVED THE DEVICE WHEN THEY ARRIVED. THE PATIENT WAS IN ASYSTOLE. THE TM HAD EQUIPMENT AND REPORTED THAT THE LCD SCREEN WAS CRACKED, BUT THE SPEAKER WORKS. APPROXIMATELY THREE HOURS LATER TM CONTACTED SUPPORT. TM HAD INTERVIEWED A WITNESS TO THE EVENT. THE WITNESS STATED THAT THE PATIENT WHO WAS A LARGE MAN COLLAPSED BETWEEN A KITCHEN CART AND A WALL. SHE STATED THAT THE SURVEILLANCE CAMERA INDICATED TIME TO BE APPROXIMATELY 7:10PM CST. IT TOOK FIVE PEOPLE TO MOVE THE PATIENT INTO AN OPEN AREA. THE PATIENT APPEARED TO BE BREATHING. NINE ONE ONE WAS CALLED AT 7:12 AND ARRIVED AT 7:20. WITNESS STATED THE DEVICE WAS ANNUNCIATING "TO ACTIVATE DEVICE PLEASE PRESS RESPONSE BUTTONS" OVER AND OVER AGAIN. SHE PRESSED ONLY THE FRONT RESPONSE BUTTON, BUT COULD NOT GET THE DEVICE TO ACTIVATE. TM SPOKE TO EMS PERSONNEL IN 2008. THEY STATED THAT A RN HAD ARRIVED BEFORE THEM. AGAIN SHE STATED THAT THE DEVICE WAS ANNUNCIATING "TO ACTIVATE DEVICE PLEASE PRESS RESPONSE BUTTONS". EMT STATED THAT WHEN THEY ARRIVED THE PATIENT WAS IN ASYSTOLE AND THEY CUT THE DEVICE OFF OF THE PATIENT. THE EMS DETECTED A RHYTHM AND TREATED PATIENT EXTERNALLY BUT THE PATIENT WENT INTO ASYSTOLE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death