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

Model Number WCD 4000

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Skin Irritation (2076); Urticaria (2278); Reaction (2414)

Event Date 07/17/2015

Event Type  Injury  

Manufacturer Narrative

Device evaluation summary: there is no indication of a device failure associated with this event.Evaluation method: code - other: biocompatibility testing to iso (b)(4) 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 skin irritation caused by the lifevest.The patient's nurse reported the patient had hives and bruising due to an allergic reaction.The patient was advised to use a cream by her physician.Follow-up indicated that the patient had begun using the cream and that the skin was healing.

• 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: alexander christie ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 5024146
• MDR Text Key: 23798954
• Report Number: 3008642652-2015-05064
• 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
• Report Date: 08/17/2015

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: Not provided
• Initial Date FDA Received: 08/23/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 68 YR