LIFEVEST WCD 4000 SYSTEM
Report
- Report Number
- 3008642652-2016-00636
- Event Type
- Injury
- Date Received
- February 6, 2016
- Date of Event
- January 10, 2016
- Report Date
- March 23, 2016
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENTS. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION THE MONITOR WAS RESETTING DURING INCOMING PULSE TESTING. THERE IS NO INDICATION THAT THIS FAILURE CAUSED OR CONTRIBUTED TO THE INAPPROPRIATE TREATMENT EVENT. THE MONITOR WAS STILL ABLE TO DELIVER A FULL ENERGY PULSE DURING THE TREATMENT EVENT. THE ROOT CAUSE FOR THE RESETS WAS ISOLATED TO NOISE ORIGINATING FROM THE DEFIBRILLATOR PCA HIGH-VOLTAGE CAPACITORS AND PROPAGATING ON THE MAIN BATTERY WIRE ON THE MONITOR C/A BOARD. PMA SUPPLEMENT P010030/S064 WAS SUBMITTED TO FDA ON 07/06/2015 AND WAS APPROVED ON 11/06/2015. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION IN THE FIELD. BELT SN (B)(4) WAS RETURNED AND EVALUATED AT THE DISTRIBUTOR, IN ACCORDANCE WITH PROCEDURES RECOMMENDED BY ZOLL MANUFACTURING CORPORATION. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT AND INCOMING FUNCTIONAL TESTING. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE INAPPROPRIATE TREATMENT DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, FOLLOWED BY A 5HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5HZ SIGNAL, THE DEVICE WAS CONFIRMED TO PROPERLY ENTER INTO A TREATMENT SEQUENCE WHICH INCLUDES A VERIFICATION OF THE TACTILE VIBRATION ALARM, AUDIO MESSAGING, AND SIREN ALARMS, AS WELL AS A TEST OF THE PULSE DELIVERY CIRCUITRY. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER CHARGING OF THE HIGH VOLTAGE CAPACITORS AND PROPER DELIVERY OF FIVE FULL ENERGY 150J BIPHASIC PULSES. THE FUNCTIONAL TESTING CONFIRMED PROPER RESPONSE BUTTON FUNCTIONALITY, ECG ACQUISITION, DETECTION ALGORITHM PERFORMANCE, AND PULSE DELIVERY FUNCTIONALITY. DEVICE EVALUATION SUMMARY: ELECTRODE BELT SN (B)(4) AND MONITOR SN (B)(4) HAVE BEEN RECOVERED FROM THE FIELD AND ARE AWAITING EVALUATION. DEVICE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE INAPPROPRIATE TREATMENT. TE PLACEMENT FAULT FLAGS WERE OBSERVED IN THE DOWNLOAD AND EVALUATED. IT WAS DETERMINED THAT THESE FAULT FLAGS WERE UNASSOCIATED WITH THE INAPPROPRIATE SHOCK AND NOT A REPORTABLE DEVICE MALFUNCTION. AWAITING MONITOR AND ELECTRODE BELT EVALUATIONS. DEVICE MANUFACTURE DATE: MONITOR:06/13/2014. ELECTRODE BELT:01/31/2011. THE INVESTIGATION INTO THE EVENT CONCLUDES THAT THERE WAS NO DEVICE MALFUNCTION. A CAUSE AND EFFECT ANALYSIS WAS CONDUCTED USING ALL OF THE AVAILABLE INFORMATION WHICH INCLUDES THE INCIDENT REPORT, SOFTWARE FLAG FILES, AND ECG STRIPS. THE PRIMARY CAUSE OF THE INAPPROPRIATE SHOCK WAS IMPROPER RESPONSE BUTTON USE. THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS NSVT. INAPPROPRIATE DEFIBRILLATIONS ARE AN ANTICIPATED RISK ASSOCIATED WITH THE USE OF THE LIFEVEST. PATIENTS ARE INSTRUCTED THROUGH ALARMS, VOICE MESSAGES, IFU, AND TRAINING TO PRESS THE RESPONSE BUTTONS TO PREVENT AN INAPPROPRIATE DEFIBRILLATION. THE CURRENT COMMERCIAL INAPPROPRIATE DEFIBRILLATION RATE IS CONSISTENT WITH THE OBSERVED RATE DURING THE PIVOTAL CLINICAL TRIAL G960083 (0.69% PER PATIENT-MONTH WITH 90% CONFIDENCE). A SUMMARY OF THE SAFETY AND EFFECTIVENESS DATA (SSED), INCLUDING THE INAPPROPRIATE DEFIBRILLATION SAFETY OBJECTIVE SUPPORTING FDA'S APPROVAL OF THE LIFEVEST, CAN BE FOUND AT (HTTP://WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF/P010030B.PDF). THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH IEC 60601-2-4 PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.
THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENTS. DEVICE EVALUATION SUMMARY: ELECTRODE BELT SN (B)(4) AND MONITOR SN (B)(4) HAVE BEEN RECOVERED FROM THE FIELD AND ARE AWAITING EVALUATION. DEVICE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE INAPPROPRIATE TREATMENT. TE PLACEMENT FAULT FLAGS WERE OBSERVED IN THE DOWNLOAD AND EVALUATED. IT WAS DETERMINED THAT THESE FAULT FLAGS WERE UNASSOCIATED WITH THE INAPPROPRIATE SHOCK AND NOT A REPORTABLE DEVICE MALFUNCTION. AWAITING MONITOR AND ELECTRODE BELT EVALUATIONS DEVICE MANUFACTURE DATE: MONITOR:06/13/2014; ELECTRODE BELT:01/31/2011. ADDITIONAL INAPPROPRIATE DEFIBRILLATION NARRATIVE: THE INVESTIGATION INTO THE EVENT CONCLUDES THAT THERE WAS NO DEVICE MALFUNCTION. A CAUSE AND EFFECT ANALYSIS WAS CONDUCTED USING ALL OF THE AVAILABLE INFORMATION WHICH INCLUDES THE INCIDENT REPORT, SOFTWARE FLAG FILES, AND ECG STRIPS. THE PRIMARY CAUSE OF THE INAPPROPRIATE SHOCK WAS IMPROPER RESPONSE BUTTON USE. THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS NSVT. INAPPROPRIATE DEFIBRILLATIONS ARE AN ANTICIPATED RISK ASSOCIATED WITH THE USE OF THE LIFEVEST. PATIENTS ARE INSTRUCTED THROUGH ALARMS, VOICE MESSAGES, IFU, AND TRAINING TO PRESS THE RESPONSE BUTTONS TO PREVENT AN INAPPROPRIATE DEFIBRILLATION. (B)(4). A SUMMARY OF THE SAFETY AND EFFECTIVENESS DATA (SSED), INCLUDING THE INAPPROPRIATE DEFIBRILLATION SAFETY OBJECTIVE SUPPORTING FDA'S APPROVAL OF THE LIFEVEST, CAN BE FOUND AT (HTTP://WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF/P010030B.PDF). THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH IEC 60601-2-4 PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.
A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT CONSISTING OF ONE SHOCK. IT WAS REPORTED THAT THE PATIENT WAS AT HOME AND CONSCIOUS AT THE TIME OF THE EVENT. NONSUSTAINED VENTRICULAR TACHYCARDIA (NSVT) CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE PRESSED DURING THE EVENT AFTER TREATMENT WAS DELIVERED THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. THE PATIENT DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT.
A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT CONSISTING OF ONE SHOCK. IT WAS REPORTED THAT THE PATIENT WAS AT HOME AND CONSCIOUS AT THE TIME OF THE EVENT. NONSUSTAINED VENTRICULAR TACHYCARDIA (NSVT) CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE PRESSED DURING THE EVENT AFTER TREATMENT WAS DELIVERED THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. THE PATIENT DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73413 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other |