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

Model Number WCD 4000

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Weakness (2145); Loss of consciousness (2418)

Event Date 10/31/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, zoll was notified that a patient was reanimated in the hospital on (b)(6) 2014 where he was fit with the lifevest one hour prior.He was reportedly wearing the lifevest and wanted to get out of bed.He began to feel weak and lost consciousness.Reportedly, there were no messages or a siren alert.The lifevest did not treat the patient.The patient was being monitored by telemetry.The clinical staff decided to externally defibrillate the patient.Additionally, the patient was also connected to a bedside respiration monitor (intelli vue x2, (b)(4)).

Manufacturer Narrative

There was no death or device malfunction associated with the event.There is also no indication of a serious injury.Review of the patient's downloaded data does not indicate that a treatable arrhythmia was detected.Through review of the downloaded data, there does not appear to be any equipment deficiences.The equipment is in the process of being returned for further evaluation.Monitor (b)(4) - reuse, electrode belt (b)(4) : 01/2012 - initial use.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA
• Manufacturer Contact: nina rudolph ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4301415
• MDR Text Key: 17626450
• Report Number: 3008642652-2014-04503
• 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
• Type of Report: Initial
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• 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: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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): Other
• Patient Age: 52 YR