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

Model Number WCD 4000

Device Problem Leak/Splash (1354)

Patient Problem Skin Irritation (2076)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces of the lifevest device as well as the blue(tm) defibrillation gel.Device evaluation of electrode belt sn (b)(4) was completed.The reported problem (gel leak) was confirmed.Upon investigation gel was leaking from the rear 1 therapy electrode.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes.The pulse delivery circuitry test verified proper delivery of full energy 150j biphasic pulse.The functional testing confirmed proper ecg acquisition and pulse delivery functionality.The root cause of the gel leak was unable to be positively identified.

Event Description

A us distributor reported that a patient had developed a skin irritation under the back therapy electrodes.The patient reported that one of the back therapy electrodes was leaking a substance.The patient reported that their doctor stated that the irritation may have been a burn.The patient's doctor prescribed the patient ascend silver sulfadiazine urea ointment for the reported irritation.The patient was issued a replacement electrode belt.After using the ointment on the skin irritation, the patient reported that the irritation had improved.

• 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: johnna dominick ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 6804085
• MDR Text Key: 83028065
• Report Number: 3008642652-2017-06969
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005012
• UDI-Public: 00855778005012
• 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: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2011
• 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): Required Intervention
• Patient Age: 43 YR