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

Model Number 80014-002

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2024

Event Type  malfunction  

Event Description

Service error code was received on the customer support helpline queue.Patient reported that they were unable to clear the service error code and device is alerting nonstop.Customer care attempted to troubleshoot but was unable to resolve the issue.There was no patient injury or adverse event.However, 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.

• Brand Name: ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR
• 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: 18895072
• MDR Text Key: 337569081
• Report Number: 3015185344-2024-00068
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00840241600238
• UDI-Public: (01)00840241600238(11)230720
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 80014-002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2023
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 66 KG