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

Model Number	80014-001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	05/02/2023
Type of Reportable Event	Death
Event or Problem 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.
Additional Manufacturer Narrative
The wcd system was not recovered from the field.Patient's caregiver reported that the patient passed away due to congestive heart failure.The wcd system is not indicated for the treatment of congestive heart failure and was removed from the patient prior to death.Wcd role in patient death is unrelated.

• Brand Name: ASSURE CARDIAC RECOVERY SYSTEM
• 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 ; 2069701994
• MDR Report Key: 17751295
• Report Number: 3015185344-2023-00136
• Device Sequence Number: 17796696
• Product Code: MVK
• UDI-Device Identifier: 00840241600047
• UDI-Public: (01)00840241600047(11)221213
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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: 80014-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 328 KG