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

Model Number 80014-001

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2022

Event Type  Death  

Event Description

Patient was fitted on (b)(6) 2022.Scheduled 48-hour check-in follow-up calls to the patient on (b)(6) 2022 and (b)(6) 2022 were unanswered.Daughter states that on (b)(6)2022, she found her mother on the bathroom floor mumbling to her.Daughter reports that the patient was wearing the wcd and that the wcd gave an alert that "the patient is unconscious and to call 911".Daughter began doing cpr on her mother and when ems arrived, they took over resuscitation efforts.The patient did not survive.

Manufacturer Narrative

Cause of death is pending coroner's report.Investigation of device is pending coroner's release and return to manufacturer.

• 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
• MDR Report Key: 13772924
• MDR Text Key: 287241941
• Report Number: 3015485344-2022-00003
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00840241600047
• UDI-Public: (01)00840241600047(11)220121
• 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
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: No
• 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: 03/03/2022
• Initial Date FDA Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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 Outcome(s): Death
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 83 KG