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

Model Number 80014-001

Device Problem Insufficient Information (3190)

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

Event Date 10/31/2022

Event Type  malfunction  

Event Description

During the initial check-in call the patient reported the wcd not working.The patient inserted the battery into the system but the wcd was stuck in boot up with the blue light on and the spinning wheel indicating it is loading.It never got past that state, or alerted for any issue.It just did not boot up fully to system ready status with the green light and check mark.Note: one day earlier on (b)(6) 2022, patient reported taking off the wcd to shower (unsnapped garment and put on the ground and unplugged the device).After showering, put the battery back in and then plugged in the device.Once plugging in there was no display.Customer support had the patient take the battery out and put it back in to see if that would help.Once taking out the battery and putting it back in the device, the lcd powered up and seemed to work ok.

Manufacturer Narrative

Device evaluation of the alleged malfunction required retrieval of the device from the patient; return to the contact manufacturer for decontamination, inspection and initial testing; followed by shipment to the manufacturer of record for failure investigation and root cause analysis.Kmt engineering evaluated the monitor and found no visible indentations on the outside of the monitor.The reported issue was caused due to a power supply slew-rate limitation where the som does not boot up with too-fast of a power supply slew rate.This intermittent failure mode has been identified and corrected in assemblies.The issue does not appear to be occurring at a rate significant enough to take further action.The issue will continue to be trended for future occurrences.

• 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: 15722404
• MDR Text Key: 307176940
• Report Number: 3015185344-2022-00023
• Device Sequence Number: 1
• Product Code: MVK
• 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: 11/04/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 80014-001
• Device Catalogue Number: 80014-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/03/2022
• Supplement Dates Manufacturer Received: 10/31/2022
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 74 KG