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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Defibrillation/Stimulation Problem (1573); Device Sensing Problem (2917)

Patient Problem Electric Shock (2554)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Type of reportable event: there was no death or device malfunction associated with the inappropriate defibrillation event.Device evaluation summary: electrode belt sn (b)(4) and monitor sn (b)(4) were recovered from the field and the device evaluation is currently underway.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.  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 (patient error).The ecg analysis, conducted by trained ecg technicians, identified the primary cause of the false detection was motion artifact.The source of the artifact could not be positively identified through cause and effect analysis.The following could not be ruled out as contributing factors: body motion, poor ecg contact with skin.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.

Event Description

A us distributor contacted zoll to report that a patient experienced a defibrillation event consisting of one shock.It was reported that the patient was working with a drilling machine and a hearing protector at the time of the time of the event.Per the patient's ecg preceding the treatment, the patient's rhythm was obscured by motion artifact.Motion artifact contributed to the false detection.The patient was then treated, and the patient's ecg rhythm at the time of the treatment is unknown.The patient reported that he felt his skin getting wet and then he turned off the hearing protector and heard the device alarming.The patient removed the battery before receiving the shock.The device delivered a pulse of 2 j which is consistent with the battery pack being removed directly before the pulse delivery.The response buttons were not pressed during the event.The patient did not seek medical attention and continued wearing the lifevest. .

• 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: brooke arnold ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 8846857
• MDR Text Key: 152836206
• Report Number: 3008642652-2019-06025
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2019

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?: Yes
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2015
• 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: 54 YR