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

Model Number	80014-002
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2026
Type of Reportable Event	Death
Event or Problem Description
Kmts field rep reported a shock delivered and patient death.It is not clear whether the shock occurred before death or after and no further information was available.

• Brand Name: ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR
• Common Device Name: 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 ; +1(206)970-1994
• MDR Report Key: 50501680
• Report Number: 3015185344-2026-00409
• Device Sequence Number: 15810340
• Product Code: MVK
• UDI-Device Identifier: 00840241600238
• UDI-Public: (01)00840241600238(11)260122
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P200037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 80014-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 149 LB