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

Model Number WCD 4000

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Skin Discoloration (2074); Skin Irritation (2076); Reaction (2414)

Event Date 07/13/2020

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¿ defibrillation gel.

Event Description

A us distributor contacted zoll to report that a patient developed a skin irritation.The irritation was described as darkened, red, itchy, and appears as bumps.The patient stated the irritation appeared as a skin reaction.The patient reported to be taking blood thinners.The patient confirmed she has a history of sensitive skin and is allergic to different metals.There was no alleged device malfunction contributing to the irritation.Patient was seen by a physician.The patient initially used calamine lotion on her own, but then was prescribed flonase by a medical professional.The patient also used benadryl but its unclear if this was prescribed by the physician.The outcome is unknown as the patient stated she would speak with her doctor.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer Contact: kevin chan ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 10378181
• MDR Text Key: 202005805
• Report Number: 3008642652-2020-06685
• Device Sequence Number: 1
• Product Code: MVK
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• 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
• Date Manufacturer Received: 07/28/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR