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

Model Number	80014-001
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This file was originally submitted on 06/04/2025 but was not ack3 acknowledged as passed.It is being resubmitted with this statement on advice of the cdrh mdr team at opeq, office of regulatory programs, division of surveillance support.
Event or Problem Description
Patient's doctor from er reported patient arrived via ambulance and stated they received therapeutic shock three times.The reported injury was not life-threatening, did not result in permanent damage, or necessitate medical intervention to preclude permanent damage.However, an undiverted shock to a conscious patient could result in serious injury.
Additional Manufacturer Narrative
Device evaluation of the alleged malfunction required retrieval of the device from the patient; return to the contract manufacturer for decontamination, inspection, and initial testing; followed by shipment to the manufacturer of record for failure investigation and root cause analysis.The returned device was evaluated, and the monitor passed all evaluation tests.Returned therapy cable could not be tested due to shock delivery and gel deployment which confirms that the therapy cable functioned as expected.There was no observed damage, and all gel was deployed during the event.Evaluation evidence indicates wcd performed per prescription and intended use.Patient was fit and trained prior to initial use, including the use of the heart alert button to cancel the shock.However, patient heard and felt the alert but did not cancel the shock using the wcd heart alert button.

• 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 ; 2069701994
• MDR Report Key: 23596142
• Report Number: 3015185344-2025-00146
• Device Sequence Number: 21452052
• Product Code: MVK
• UDI-Device Identifier: 00840241600047
• UDI-Public: (01)00840241600047(11)220921
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 80014-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• 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
• Patient Sex: Male