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

Model Number WCD 4000

Device Problems Leak/Splash (1354); Compatibility Problem (2960)

Patient Problem Skin Irritation (2076)

Event Date 07/24/2018

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.

Event Description

A distributor contacted zoll to report that a patient had a skin irritation.The patient's friend reported that one of the back therapy electrodes was leaking, causing a burn-like irritation on the patient's skin.The patient's skin was reportedly red, but was not open nor oozing.The patient reportedly received a couple of topical creams while in the hospital for an unrelated reason.The patient was not sure whether the creams were for the skin irritation or the unrelated issue.Follow-up indicated that the irritation was healing.The electrode belt has not yet been recovered from the field.The alleged gel leak cannot be confirmed at this time.

• 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: 7737072
• MDR Text Key: 115645783
• Report Number: 3008642652-2018-06691
• Device Sequence Number: 0
• Product Code: MVK
• 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: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR