AUTOCAT2 WAVE
Report
- Report Number
- 3010532612-2022-00186
- Event Type
- Malfunction
- Date Received
- May 24, 2022
- Date of Event
- April 26, 2022
- Report Date
- April 26, 2022
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DSP
- UDI-DI
- 30801902051715
- PMA / PMN Number
- K060309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
(B)(4). THERE IS AN INVESTIGATION ONGOING INTO THIS REPORTED COMPLAINT. A SUPPLEMENT FOLLOW-UP MDR REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS UPON COMPLETION OF THE INVESTIGATION.
(B)(4). TELEFLEX RECEIVED THE DEVICE FOR INVESTIGATION. THE REPORTED COMPLAINT OF BATTERY FAILED THE BATTERY LOAD TEST IS NOT CONFIRMED. THE RETURNED BATTERY PASSED VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE SERIAL NUMBER/LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. TELEFLEX ASSESSED THE RISK FOR THE REPORTED COMPLAINT. THERE ARE NO NEW OR REVISED RISK. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.
THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED BY THE FIELD SERVICE REPRESENTATIVE (FSR) THAT THE BATTERY FAILED THE BATTERY LOAD TEST.
THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED BY THE FIELD SERVICE REPRESENTATIVE (FSR) THAT THE BATTERY FAILED THE BATTERY LOAD TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1755301 | AUTOCAT2 WAVE | SYSTEM, BALLOON, INTRA-AORTIC | DSP | ARROW INTERNATIONAL LLC | IPN000320 | N/A | 30801902051715 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |