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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Fracture (1260); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/04/2012

Event Type  Injury  

Event Description

During a retroactive review of past complaints for potential adverse events, conducted as a capa in response to a recent fda inspection, a reportable adverse event was discovered.A (b)(6) year old male patient received a treatment on (b)(6) 2012 and later reported that he suffered a wrist fracture.The patient was walking at the time of the treatment.An arrhythmia was detected at 13:44:06.A 150j pulse was delivered at 13:44:50.The post-shock rhythm was dual-lead signal artifact with an underlying normal sinus rhythm.Dual-lead signal artifact contributed to the false detection.The patient reported that he pressed the response buttons but was still treated.A review of device flag data shows that the response buttons were used intermittently during the event but not directly prior to the defibrillation.The device was shutdown at 13:46:06.The patient reported falling to the ground after the treatment was delivered and fractured his wrist.On (b)(6) 2014, a zoll service representative visited the patient after the treatment, and the patient did not report any injury to his wrist at that time.On (b)(6) 2012, the patient contacted zoll to report that he had gone to the hospital and received a cast for his broken wrist.The patient continued to use the lifevest.

Manufacturer Narrative

Device evaluation summary: device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) was completed.The monitor and electrode belt were fully functional upon receipt.There was no device malfunction.Monitor: sn (b)(4), manufactured (b)(6) 2010; electrode belt: sn (b)(4), manufactured (b)(6) 2010.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOCERTER 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: 4196390
• MDR Text Key: 4983539
• Report Number: 3008642652-2014-03229
• 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
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/10/2014

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: 04/09/2012
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 78 YR