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

Model Number 80014-001

Device Problems Circuit Failure (1089); Insufficient Information (3190)

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

Event Date 01/19/2023

Event Type  malfunction  

Event Description

The patient called in to report that whenever the patient puts the battery in, the monitor gets stuck at the blue light of booting up and never moves on to yellow or green light.Customer care troubleshooted by asking the patient to remove the battery and try the alternate battery but the same issue occurred.The issue was not resolved.The defective wcd was replaced with a new unit the day after the event.However,the event was not reported to the complaints coordinator until 03/06/2023.There was no patient injury reported.However, the failure to complete the boot up process indicates a wcd system issue that if it were to recur could result in the wcd failing to provide needed therapy before a replacement can be provided.

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 monitor failed initial software load step.Kmt engineering evaluated the returned monitor and observed communication failure due to a failed advanced logic system (als) circuit.

• Brand Name: ASSURE CARDIAC RECOVERY SYSTEM
• 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: 16491930
• MDR Text Key: 310812202
• Report Number: 3015185344-2023-00026
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00840241600047
• UDI-Public: (01)00840241600047(11)221128
• 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,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 80014-001
• Device Catalogue Number: 80014-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2022
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 73 KG