FDA Adverse Event
Malfunction
Summary report: N
ACAT 1 IAB PUMP ASSEMBLY JAPANESE
MDR report key: 1230363
·
Received November 7, 2008
Report
- Report Number
- 1219856-2008-00524
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- November 1, 2008
- Report Date
- November 7, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K965209
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE IN THE CATH LAB THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB), A "ZEON MEDICAL 7FR." AFTER THE IAB WAS INSERTED, THE PUMP WAS TURNED ON. THE PUMP MADE A STRANGE SOUND "LIKE A VIBRATION OCCURRED" THEN ALARMED "PURGE FAILURE" AND THEN STOPPED WORKING. AS A RESULT, THE PUMP WAS EXCHANGED. A REQUEST WAS MADE FOR MORE INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACAT 1 IAB PUMP ASSEMBLY JAPANESE | INTRA-AORTIC BALLOON PUMP PRODUCTS | DSP | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | INTRA-AORTIC BALLOON| ZEON MEDICAL |