MAUDE Adverse Event Report: KESTRA MEDICAL TECHNOLOGIES, INC. ASSURE CARDIAC RECOVERY SYSTEM; WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number 80014-001

Device Problem Insufficient Information (3190)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 05/02/2023

Event Type  Death  

Event Description

The patient's friend stepped out of the room to get some ice and on return the patient was found unresponsive.When asked if a family member knew whether the patient was wearing the wcd at the time, the answer was affirmative.The wcd was cut off the patient by the persons that responded to the 911 call -- and the responders disposed of the wcd.The family member reported cause of death as congestive heart failure.Because the wcd was destroyed, the patient's event logs and episode reports are not available for further investigation.

• Brand Name: ASSURE CARDIAC RECOVERY SYSTEM
• Type of Device: WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): KESTRA MEDICAL TECHNOLOGIES, INC.; 3933 lake washington blvd ne; ste 200; kirkland WA 98033
• Manufacturer (Section G): KESTRA MEDICAL TECHNOLOGIES, INC.; 3933 lake washington blvd ne; ste 200; kirkland WA 98033
• Manufacturer Contact: jay wiese ; 3933 lake washington blvd ne; ste 200; kirkland, WA 98033 ; 2069701994
• MDR Report Key: 17751295
• MDR Text Key: 323465229
• Report Number: 3015185344-2023-00136
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00840241600047
• UDI-Public: (01)00840241600047(11)221213
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 80014-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2022
• 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): Death
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 149 KG