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

Model Number WCD 4000

Device Problem Insufficient Information (3190)

Patient Problem Allergic reaction (1701)

Event Date 06/16/2014

Event Type  Injury  

Event Description

A (b)(6) patient's nurse contacted zoll customer support to report that the patient had skin sore underneath the therapy electrodes.It was reported that the patient has open wounds which sometimes bleed.The patient's doctor confirmed the patient has an allergic reaction to the lifevest.In addition, it was also reported that there was a small gel leak from the therapy electrode.There was no allegation that this contributed to the allergic reaction.

Manufacturer Narrative

Device evaluation summary: biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces of the lifevest device.The therapy electrodes contain a small amount of nickel, which is a known allergen.Evaluation of belt (b)(4) has been completed.The reported problem (gel leak) was confirmed.Upon evaluation, there was gel leaking from one blister in the rear 1 therapy electrode.There was no allegation that the gel leak contributed to the allergic reaction.Biocompatibility testing to iso 10993 was also successfully completed on the gel.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: katelynn mains ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 3952069
• MDR Text Key: 4642026
• Report Number: 3008642652-2014-02223
• 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: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/14/2014

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
• Date Returned to Manufacturer: 06/28/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2014
• Initial Date FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR