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

Model Number	80014-001
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Service error code was received on the customer support helpline queue.The service required event code indicates a wcd system issue that if it were to recur could result in the wcd failing to provide needed therapy.
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.Returned therapy cable passed safety but failed inspection for unrelated issue.The returned monitor was tested at benchmark and passed both isl (safety) and eit (performance) testing.The reported condition was not able to be replicated.The reported service error code alert can be attributed to a system power-on self-test fault detected when a patient plugs and unplugs the therapy cable during system boot up.Will continue to monitor and trend service code issues for failure modes.

• 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: 18085883
• Report Number: 3015185344-2023-00197
• Device Sequence Number: 7823208
• Product Code: MVK
• UDI-Device Identifier: 00840241600047
• UDI-Public: (01)00840241600047(11)230711
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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: 11/03/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 248 KG