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

Model Number WCD 4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Dizziness (2194); Hip Fracture (2349); Loss of consciousness (2418)

Event Date 01/24/2011

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 nurse contacted zoll customer support on (b)(6) 2011 to report that a (b)(6) male patient was treated.The nurse stated that the patient reported walking into (b)(6) when he started to feel light-headed and lost consciousness.The patient reported that he did not remember being shocked.The nurse reported that the patient fell and has a broken hip.The patient underwent surgery on (b)(6) 2011.

Manufacturer Narrative

Per review of the treatment event, the patient experienced an inappropriate defibrillation event on (b)(6) 2011 at 12:34pm.Signal artifact contributed to the false detection.The response buttons were not used during the event.There are no allegations that the inappropriate defibrillation caused or contributed to the patient's fail; however, zoll cannot definitively rule out the inappropriate treatment as a contributing cause of the fall and resulting serious injury.Device evaluation summary: device evaluation of monitor sn: (b)(4) and electrode belt sn: (b)(4) were completed.The monitor and electrode belt were fully functional upon receipt.Monitor sn: (b)(4), electrode belt sn (b)(4): 11/2013 - reuse.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.The current commercial inappropriate defibrillation rate is consistent with the observed rate during the pivotal clinical trial (b)(4).A summary of the safety and effectiveness data (ssed), including the inappropriate defibrillation safety objective supporting fda's approval of the lifevest, can be found at http://www.Accessdata.Fda.Gov/cdrh_docs/pdf/p010030b.Pdf.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: allison petzold ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4261772
• MDR Text Key: 5049917
• Report Number: 3008642652-2014-03855
• 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: 11/10/2014

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: 02/28/2011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR