FDA Adverse Event
Malfunction
Summary report: N
ASSURE CARDIAC RECOVERY SYSTEM
MDR report key: 16448926
·
Received February 27, 2023
Report
- Report Number
- 3015185344-2023-00021
- Event Type
- Malfunction
- Date Received
- February 27, 2023
- Date of Event
- February 26, 2023
- Report Date
- February 27, 2023
- Manufacturer
- KESTRA MEDICAL TECHNOLOGIES, INC.
- Product Code
- MVK
- UDI-DI
- 00840241600047
- PMA / PMN Number
- P200037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
DEVICE EVALUATION OF THE ALLEGED MALFUNCTION REQUIRED RETRIEVAL OF THE DEVICE FROM THE PATIENT; RETURN TO THE CONTRACT MANUFACTURER FOR DECONTAMINATION, INSPECTION AND INITIAL SAFETY AND PERFORMANCE TESTING. RETURNED THERAPY CABLE PASSED WEIGHT AND FAILED SAFETY FOR ISOLATION BETWEEN HIGH VOLTAGE AND LOW VOLTAGE CIRCUITS. KMT ENGINEERING EVALUATED THE RETURNED THERAPY CABLE AND OBSERVED SHORT FROM ANTERIOR TO SHIELD WHICH CAUSED THE SERVICE ERROR CODE.
Description of Event or Problem · 0
PATIENT REPORTED RECEIVING R204E( HVM NW H-BRIDGE LEAKAGE TEST FAILURE) SERVICE REQUIRED CODES. THERE WAS NO PATIENT INJURY. THE SERVICE REQUIRED EVENT CODE INDICATES A WCD SYSTEM ISSUE THAT IF IT WERE TO RECUR COULD RESULT IN THE WCD FAILING TO PROVIDE NEEDED THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 798899 | ASSURE CARDIAC RECOVERY SYSTEM | WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR | MVK | KESTRA MEDICAL TECHNOLOGIES, INC. | 80014-001 | 00840241600047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male |