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

Model Number WCD 4000

Device Problems Leak/Splash (1354); Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Date 10/08/2018

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.Electrode belt sn (b)(4) was returned and evaluated at the distributor in accordance with procedures recommended by zoll manufacturing corporation.The evaluation included download data review and incoming functional testing.During the incoming functional testing, the ecg acquisition and pulse delivery circuitry were verified.Upon evaluation, there was no evidence of a gel leak from any of the therapy electrode.

Event Description

A us distributor reported that the patient had developed a red, itchy rash under the back therapy electrodes.The patient's nurse indicated that the belt was leaking gel from the right therapy electrode and suggested to use hydrocortisone cream on the rash.After using the cream, the patient's rash did not improved.The patient's physician suggested to use neosporin on the rash instead.Since using the neosporin, the patient's rash has 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: andrew becker ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 8056108
• MDR Text Key: 126701885
• Report Number: 3008642652-2018-09135
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• 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: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Age: 58 YR