MAUDE Adverse Event Report: ZOLL MEDICL LIFEVEST; EXTERNAL CARDIAC DEFIBRILATOR

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Defibrillation/Stimulation Problem (1573)

Patient Problem Death (1802)

Event Date 12/21/2015

Event Type  malfunction  

Event Description

A (b)(6) pt with history of stroke, diabetes, cad and copd was admitted to post-acute rehab facility following treatment for an acute mi.A physical therapist entered the pt's room for a scheduled therapy session.The pt was found unresponsive.The pt was wearing a lifevest, however, the lifevest did not alarm or shock.A code blue was called, cpr was initiate and the pt was transported to the ed by ems.The pt expired and the lifevest was returned to the vendor for analysis.

• Brand Name: LIFEVEST
• Type of Device: EXTERNAL CARDIAC DEFIBRILATOR
• Manufacturer (Section D): ZOLL MEDICL ; pittsburgh PA
• MDR Report Key: 5528867
• MDR Text Key: 41318335
• Report Number: MW5061256
• Device Sequence Number: 1
• Product Code: MVK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR