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

Model Number 80014-001

Device Problems Insufficient Information (3190); Component Misassembled (4004)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

Patient reported an error code posted on the system as a service required alert for hvm inrush circuit test failure (r204b).Kmts customer support attempted to resolve alert through instructions to patient to remove and reinsert the battery.However, wcd continued to issue the service required alert.

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.The failure can be duplicated, however, the error code reported is r2049 and not r204b as reported by the patient.R2049 is the only error logged in the system log for the time in which the patient was wearing the monitor.The error was repeated in 5 out of 6 boot ups indicating that the issue is somewhat intermittent.The r2049 error is caused by a loose screw connection to the dump resistor.From the top of the board stack, the screw is not fully tightened resulting in an intermittent connection.When turned, the screw just spins indicating that the screw on the bottom of the board stack is also loose and the whole standoff is spinning.A bad connection on the dump resistor has been confirmed to cause the r2049 error.The root cause for this failure has been determined to be an incorrectly inserted screw for the dump resistor connection to the board stack.This is considered an isolated, single occurrence failure of this type.The monitor was in-process reworked but the system pcba was not re-torqued.Operators were retrained to be aware of this failure mode.

• 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: 13773004
• MDR Text Key: 288105798
• Report Number: 3015185344-2022-00004
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00840241600047
• UDI-Public: (01)00840241600047(11)211014
• 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: 03/15/2022

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: 03/01/2022
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 95 KG