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

Model Number 80014-001

Device Problems Electrical Shorting (2926); Insufficient Information (3190)

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

Event Date 05/01/2022

Event Type  malfunction  

Event Description

Rn at patient's facility reported the assure wcd monitor displaying a service required indicator (displayed as a wrench icon with code r2052).The code advises of a system self-test failure for the high voltage module for the anterior defibrillation electrode.There was no associated patient injury.The suspected deficient system was replaced on the same day.

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 therapy cable was covered in gel when returned from the field.There was gel on the plug causing a leakage path between the anterior electrode and ground (plug shell) which was leading to the r2052 error.This is supported by the following test performed during failure investigation: the plug was found with gel in the anterior hole and also around the grounded shield.The gel was washed off before the first test and it booted without error.The r2052 error code came back after adding gel in a way to replicate the initial finding.The r2052 error code finally went away after a good plug cleaning with isopropyl alcohol (ipa).The cable has a leakage path across the isolation barrier.It failed dielectric safety (hipot) and can be measured with a digital mult-meter (dmm) in the 200k to 500k ohm range.

• Brand Name: ASSURE CARDIAC RECOVERY SYSEM
• 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: 14457882
• MDR Text Key: 300322495
• Report Number: 3015185344-2022-00006
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00840241600047
• UDI-Public: (01)00840241600047(11)220323
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

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?: No
• Initial Date Manufacturer Received: 05/01/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 05/01/2022
• Supplement Dates FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• 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: 56 YR
• Patient Sex: Male