FDA Adverse Event
Malfunction
Summary report: N
AUTOCAT2 WAVE
MDR report key: 1492073
·
Received August 21, 2009
Report
- Report Number
- 1219856-2009-00388
- Event Type
- Malfunction
- Date Received
- August 21, 2009
- Date of Event
- May 19, 2009
- Report Date
- August 21, 2009
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DSP
- PMA / PMN Number
- K060309
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). PER THE FIELD SERVICE REPORT, AFTER THE FOS SLIDER WAS REPLACED, THE FOS READINGS WERE LOW. THE FOS PCB WAS REPLACED AND THE IABP PASSED FUNCTIONAL TESTING. NO PARTS OR RECORDER STRIPS WERE RETURNED FOR EVALUATION. IT WAS CONFIRMED, THE FOS PCB WAS CAUSING INACCURATE FOS READINGS.
Description of Event or Problem · 1
IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM - PERFORMED PREVENTATIVE MAINTENANCE. FINDINGS/ACTION TAKEN: REPLACED FIBEROPTIX SENSOR (FOS) SLIDER. FOS READINGS 15% LOW. REPLACED FOS PRINTED CIRCUIT BOARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOCAT2 WAVE | INTRA-AORTIC BALLOON PUMP PRODUCTS | DSP | ARROW INTERNATIONAL INC. | KP5123573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |