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

Model Number	80014-001
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient received a therapeutic shock while wearing the wcd in hospital following an unrelated surgery.Spouse reported the patient was lightly sedated and restrained while on a ventilator and unable to divert the shock.Spouse reported that nurses were independently aware of patient's high heart rate over an extended period of time but would not have shocked the patient.Customer care advised the patient's spouse that the wcd is not intended for in-hospital use and advised the spouse speak to patient's healthcare provider about removing the system.
Additional 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 device was evaluated and the monitor passed all evaluation tests.Returned therapy cable could not be tested due to shock delivery and gel deployment which confirms that the therapy cable functioned as expected.There was no observed damage and all gel was deployed during the event.Evaluation evidence indicates wcd detected a shockable rhythm inappropriate to its indication for use.

• Brand Name: ASSURE CARDIAC RECOVERY SYSTEM
• Common Device Name: 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
• MDR Report Key: 17865670
• Report Number: 3015185344-2023-00145
• Device Sequence Number: 12635036
• Product Code: MVK
• UDI-Device Identifier: 00840241600047
• UDI-Public: (01)00840241600047(11)230711
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P200037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 80014-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 85 KG