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

Model Number WCD 4000

Device Problem Seal, defective (2301)

Patient Problem Burn(s) (1757)

Event Date 01/03/2015

Event Type  Injury  

Event Description

A zoll distributor reported that a (b)(6) male patient received an inappropriate treatment.On (b)(6) 2015, the patient received a treatment at 03:16:29 while sleeping.The rhythm at the time of the treatment was bradycardia with tall t waves and motion artifact.Multiple counting of the patient's rhythm contributed to the false detection.The patient did not press the response buttons prior to the treatment.The patient reported that the lifevest did not deploy gel and that the treatment had burned him.The patient went to the hospital for further evaluation.A distributor follow-up on (b)(6) 2014 indicated that the burn was improving.

Manufacturer Narrative

Device evaluation: device evaluation of electrode belt sn (b)(4) was completed.The reported problem (gel not deployed) was confirmed.Upon investigation the rear therapy electrodes properly deployed gel but the front therapy electrode did not deploy gel.The cause for the gel deployment failure was a leak in the seal surrounding the therapy electrode gas generator o-ring.The leak allowed the gas from the gas generator to escape through the leak instead of forcing gel out of the exit ports of the therapy electrode.The root cause for the o-ring leak could not be positively identified.The lifevest electrode belt therapy electrodes have a surface area well above (b)(4) requirements.The larger surface area helps to limit the risk of a patient receiving a burn if the electroconductive gel does not fully deploy.Additional inappropriate defibrillation narrative: inappropriate defibrillations are an anticipated risk associated with the use of the lifevest.Patients are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation.(b)(4).

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: zachary nelson ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4476100
• MDR Text Key: 5401373
• Report Number: 3008642652-2015-00443
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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): Hospitalization; Other
• Patient Age: 65 YR