LIFEVEST WCD 4000 SYSTEM
Report
- Report Number
- 3008642652-2015-04834
- Event Type
- Death
- Date Received
- August 4, 2015
- Date of Event
- June 24, 2015
- Report Date
- February 4, 2016
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
EVALUATION OF THE EQUIPMENT ASSOCIATED WITH THE 113J TREATMENT AND PATIENT DEATH IS STILL UNDERWAY. MONITOR SN (B)(4) WAS RETURNED FOR INVESTIGATION. UPON RECEIPT THE R781 RESISTOR ON THE C/A BOARD WAS OPEN. BELT SN (B)(4) HAS NOT YET BEEN RETURNED TO ZOLL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
FURTHER INVESTIGATION OF THIS EVENT DETERMINED THAT THE MONOPHASIC PULSE WAS NOT CAUSED BY MONITOR SN (B)(4). THE DEVICE MALFUNCTION IS NOT ATTRIBUTABLE TO THE CAPACITOR TOLERANCE STACK-UP ISSUE OR PMA SUPPLEMENT P010030/S064. THE DOWNLOAD DATA INDICATES THAT THE MONOPHASIC PULSE LIKELY ORIGINATED FROM ELECTRODE BELT SN (B)(4). AFTER EXTENSIVE EFFORTS, ZOLL WAS UNABLE TO RECOVER THE ELECTRODE BELT FROM THE FIELD FOR ROOT CAUSE INVESTIGATION. THE ROOT CAUSE FOR THE MONOPHASIC PULSE CANNOT BE POSITIVELY IDENTIFIED. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE ROOT CAUSE INVESTIGATION FOUND THAT THERE IS A REMOTE POSSIBILITY THAT TOLERANCE STACK-UPS FOR FOUR CAPACITORS ON THE DEFIBRILLATOR PCA AND TWO CAPACITORS ON THE COMPUTER/ANALOG BOARD MAY INTERMITTENTLY RESULT IN A MONOPHASIC DEFIBRILLATION WAVEFORM RATHER THAN A BIPHASIC WAVEFORM. A DESIGN CHANGE TO ADDRESS THIS CONDITION (PMA SUPPLEMENT P010030/S064) WAS APPROVED BY FDA ON 11/06/2015. THE ROOT CAUSE FOR THE OPEN R781 RESISTOR WAS A NON-LIFEVEST EXTERNAL DEFIBRILLATION WHILE THE LIFEVEST WAS BEING WORN.
DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE ROOT CAUSE INVESTIGATION FOUND THAT THERE IS A REMOTE POSSIBILITY THAT TOLERANCE STACK-UPS FOR FOUR CAPACITORS ON THE DEFIBRILLATOR PCA AND TWO CAPACITORS ON THE COMPUTER/ANALOG BOARD MAY INTERMITTENTLY RESULT IN A MONOPHASIC DEFIBRILLATION WAVEFORM RATHER THAN A BIPHASIC WAVEFORM. A DESIGN CHANGE TO ADDRESS THIS CONDITION (PMA SUPPLEMENT P010030/S064) WAS APPROVED BY FDA ON 11/06/2015. THE ROOT CAUSE FOR THE OPEN R781 RESISTOR WAS A NON-LIFEVEST EXTERNAL DEFIBRILLATION WHILE THE LIFEVEST WAS BEING WORN.
ON 07/06/2015 A US DISTRIBUTOR NOTIFIED ZOLL THAT A PATIENT PASSED AWAY ON (B)(6) 2015. A REVIEW OF THE EVENT INDICATES THAT THE PATIENT WAS HOME WITH HIS WIFE AND SON WHEN HE LOST CONSCIOUSNESS. THE PATIENT RECEIVED TWO LIFEVEST TREATMENTS. THE FIRST TREATMENT WAS AT 21:24:39. THE DEVICE DELIVERED A FULL 150J PULSE. THE RHYTHM AT THE TIME OF THE TREATMENT WAS VF. THE POST-SHOCK RHYTHM WAS SINUS BRADYCARDIA AT 50 BPM. THE PATIENT'S WIFE REPORTED THAT AFTER THE FIRST TREATMENT THE PATIENT REGAINED CONSCIOUSNESS AND WAS PRESSING THE RESPONSE BUTTONS. A SECOND TREATMENT WAS DELIVERED AT 21:51:32. THE RHYTHM AT THE TIME OF THE SECOND TREATMENT WAS VT AT 235 BPM. PER FLAG FILES, THE SECOND TREATMENT WAS AN 113J MONOPHASIC PULSE AND THE ECG RHYTHM AFTER THE TREATMENT WAS NOT AVAILABLE. PER THE PATIENT'S WIFE, EMS WAS CALLED TO THEIR HOME AND HE WAS TRANSPORTED TO THE ER. PER THE ER NURSE THE PATIENT WAS EXTERNALLY TREATED FIVE TIMES WHILE WITH EMS AND ONCE AT THE ER. SHE REPORTED THAT THE LIFEVEST WAS STILL ON THE PATIENT AND THAT THE DEVICE WAS ALARMING. PER THE NURSE, THE PATIENT PASSED AWAY AT 23:25.
ON 07/06/2015 A US DISTRIBUTOR NOTIFIED ZOLL THAT A PATIENT PASSED AWAY ON (B)(6) 2015. A REVIEW OF THE EVENT INDICATES THAT THE PATIENT WAS HOME WITH HIS WIFE AND SON WHEN HE LOST CONSCIOUSNESS. THE PATIENT RECEIVED TWO LIFEVEST TREATMENTS. THE FIRST TREATMENT WAS AT 21:24:39. THE DEVICE DELIVERED A FULL 150J PULSE. THE RHYTHM AT THE TIME OF THE TREATMENT WAS VF. THE POST-SHOCK RHYTHM WAS SINUS BRADYCARDIA AT 50 BPM. THE PATIENT'S WIFE REPORTED THAT AFTER THE FIRST TREATMENT THE PATIENT REGAINED CONSCIOUSNESS AND WAS PRESSING THE RESPONSE BUTTONS. A SECOND TREATMENT WAS DELIVERED AT 21:51:32. THE RHYTHM AT THE TIME OF THE SECOND TREATMENT WAS VT AT 235 BPM. PER FLAG FILES, THE SECOND TREATMENT WAS AN 113J MONOPHASIC PULSE AND THE ECG RHYTHM AFTER THE TREATMENT WAS NOT AVAILABLE. PER THE PATIENT'S WIFE, EMS WAS CALLED TO THEIR HOME AND HE WAS TRANSPORTED TO THE ER. PER THE ER NURSE THE PATIENT WAS EXTERNALLY TREATED FIVE TIMES WHILE WITH EMS AND ONCE AT THE ER. SHE REPORTED THAT THE LIFEVEST WAS STILL ON THE PATIENT AND THAT THE DEVICE WAS ALARMING. PER THE NURSE, THE PATIENT PASSED AWAY AT 23:25.
ON (B)(6) 2015 A US DISTRIBUTOR NOTIFIED ZOLL THAT A PATIENT PASSED AWAY ON (B)(6) 2015. A REVIEW OF THE EVENT INDICATES THAT THE PATIENT WAS HOME WITH HIS WIFE AND SON WHEN HE LOST CONSCIOUSNESS. THE PATIENT RECEIVED TWO LIFEVEST TREATMENTS. THE FIRST TREATMENT WAS AT 21:24:39. THE DEVICE DELIVERED A FULL 150J PULSE. THE RHYTHM AT THE TIME OF THE TREATMENT WAS VF. THE POST-SHOCK RHYTHM WAS SINUS BRADYCARDIA AT 50 BPM. THE PATIENT'S WIFE REPORTED THAT AFTER THE FIRST TREATMENT THE PATIENT REGAINED CONSCIOUSNESS AND WAS PRESSING THE RESPONSE BUTTONS. A SECOND TREATMENT WAS DELIVERED AT 21:51:32. THE RHYTHM AT THE TIME OF THE SECOND TREATMENT WAS VT AT 235 BPM. PER FLAG FILES, THE SECOND TREATMENT WAS AN 113J MONOPHASIC PULSE AND THE ECG RHYTHM AFTER THE TREATMENT WAS NOT AVAILABLE. PER THE PATIENT'S WIFE, EMS WAS CALLED TO THEIR HOME AND HE WAS TRANSPORTED TO THE ER. PER THE ER NURSE THE PATIENT WAS EXTERNALLY TREATED FIVE TIMES WHILE WITH EMS AND ONCE AT THE ER. SHE REPORTED THAT THE LIFEVEST WAS STILL ON THE PATIENT AND THAT THE DEVICE WAS ALARMING. PER THE NURSE, THE PATIENT PASSED AWAY AT 23:25.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 505992 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death |