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

Model Number WCD 4000

Device Problem Device Sensing Problem (2917)

Patient Problems Atrial Flutter (1730); Loss of consciousness (2418); Electric Shock (2554)

Event Date 01/26/2016

Event Type  Injury  

Manufacturer Narrative

There was no death or device malfunction associated with the inappropriate defibrillation event.Device evaluation summary: electrode belt sn (b)(4) was returned and evaluated at zoll manufacturing.Monitor 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.Download fault flags were detected, but downloading is a secondary function of the device and does not prevent the device from detecting and treating a patient.Belt gel fault flags were also detected.Upon evaluation, the front therapy electrode did not deploy gel.The lack of gel deployment did not cause or contribute to the inappropriate treatment event.The impedance of the treatment shocks was well within the normal range (82 and 65 ohms, respectively).There is no indication that the lack of gel deployment from the front therapy electrode resulted in an injury.The belt is currently under engineering investigation to determine the cause of the lack of gel deployment.Device manufacture date monitor: sn (b)(4): 12/18/2012 reuse.Electrode belt: sn (b)(4): 06/17/2011 reuse.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, device evaluation, software flag files, and ecg strips.The primary cause of the inappropriate shock was improper response button use by the patient during the false detection.The response buttons were pressed, but not prior to treatment delivery.The ecg analysis, conducted by trained ecg technicians, identified the primary cause of the false detection was rapid atrial flutter.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.

Event Description

A us distributor contacted zoll to report that a patient experienced an inappropriate defibrillation event consisting of two shocks.It was reported that the patient's wife found the patient unconscious in the bathroom during the first shock.The patient's wife called emergency responders following the shock.It was reported that the patient was in the er during the second shock and that the patient's wife and the er staff witnessed the second shock.The patient remains in the hospital following the event.The response buttons were pressed during the event, but not immediately prior treatment delivery.The response buttons functioned appropriately.Rapid atrial flutter contributed to the false detection.The patient continues wearing the lifevest.There was no death or device malfunction associated with the inappropriate defibrillation event.

• 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: gabrielle salazar ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 5451566
• MDR Text Key: 38708761
• Report Number: 3008642652-2016-00985
• 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
• Report Date: 02/22/2016

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2012
• 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): Hospitalization; Other
• Patient Age: 34 YR