MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR

Model Number WCD 4000

Device Problems Defibrillation/Stimulation Problem (1573); Invalid Sensing (2293); Difficult or Delayed Activation (2577)

Patient Problem Death (1802)

Event Date 01/23/2017

Event Type  Death  

Manufacturer Narrative

Device evaluation summary: device evaluation of monitor sn (b)(4) and belt sn (b)(4) is underway.The initial 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 event.Device manufacture date: monitor: 10/07/2010, belt: 08/17/2015.

Event Description

A us distributor contacted zoll to report that a patient passed away while in a hospital.The patient's doctors indicated that they were concerned as the patient entered vf and the lifevest reportedly did not treat until 60 seconds.Review of the download data indicates that the lifevest detected an arrhythmia on (b)(6) 2017 at 05:02:32.The patient's ecg showed vf.The lifevest delivered a shock approximately 36 seconds later.The rhythm after the shock was sinus bradycardia at 55bpm.A non-treatable rhythm was detected at 5:03:31.The download data shows that the response buttons were being pressed from 5:05:27 to 5:06:59.It is unknown who pressed the response buttons during this time.A second arrhythmia was detected at 5:23:44.The patient's ecg again showed vf.The lifevest delivered a second shock approximately 53 seconds later.The rhythm after the shock was vf degrading to asystole.A third shock was delivered during asystole.Another short arrhythmia was detected at 5:26:08 for approximately 32 seconds.The patient's ecg showed vf with nsvt.A final arrhythmia was detected at 5:29:13.The patient's ecg showed cpr artifact.The lifevest delivered five shocks during this time.Cpr artifact contributed to the false detection.The device then detected a non-treatable rhythm and the device was shutdown at 7:36:18.

Manufacturer Narrative

Follow-up report - device evaluation: belt sn (b)(4) was returned and evaluated at 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 event.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.During the transition to the 5hz signal, verification of the tactile vibration alarm and testing of the pulse delivery circuitry was completed successfully.The pulse delivery circuitry test verified proper delivery of a full energy 150j biphasic pulses.The functional testing confirmed proper ecg acquisition and pulse delivery functionality.Monitor sn (b)(4) was returned and evaluated at zoll manufacturing corporation.The device evaluation of monitor sn (b)(4) has been completed.As received the monitor was unable to recognize signals from all ecgs and therapy electrodes from a test belt.Upon investigation the monitor was not properly producing a driven ground signal.The cause for the failure was isolated to an open r781 driven ground resistor on the computer/analog board.The root cause of the open resistor was unable to be positively identified but is consistent with damage sustained when a patient is externally defibrillated while wearing the device.There is no evidence that the damaged resistor caused or contributed to the patient death, as the device was able to detect an ecg and deliver full energy treatment pulses prior to the patient's passing.Device evaluation summary: device evaluation of monitor sn (b)(4) and belt sn (b)(4) is underway.The initial 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 event.Device manufacture date: monitor: 10/07/2010; belt: 08/17/2015.

Event Description

A us distributor contacted zoll to report that a patient passed away while in a hospital.The patient's doctors indicated that they were concerned as the patient entered vf and the lifevest reportedly did not treat until 60 seconds.Review of the download data indicates that the lifevest detected an arrhythmia on (b)(6) 2017 at 05:02:32.The patient's ecg showed vf.The lifevest delivered a shock approximately 36 seconds later.The rhythm after the shock was sinus bradycardia at 55bpm.A non-treatable rhythm was detected at 5:03:31.The download data shows that the response buttons were being pressed from 5:05:27 to 5:06:59.It is unknown who pressed the response buttons during this time.A second arrhythmia was detected at 5:23:44.The patient's ecg again showed vf.The lifevest delivered a second shock approximately 53 seconds later.The rhythm after the shock was vf degrading to asystole.A third shock was delivered during asystole.Another short arrhythia was detected at 5:26:08 for approximately 32 seconds.The patient's ecg showed vf with nsvt.A final arrhythmia was detected at 5:29:13.The patient's ecg showed cpr artifact.The lifevest delivered five shocks during this time.Cpr artifact contributed to the false detection.The device then detected a non-treatable rhythm and the device was shutdown at 7:36:18.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer Contact: allison petzold ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 6356741
• MDR Text Key: 68265026
• Report Number: 3008642652-2017-01542
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR