FDA Adverse Event
Malfunction
Summary report: N
PERCOR STAT DL 9.5 FR. 34 CC IAB
MDR report key: 70075
·
Received February 14, 1997
Report
- Report Number
- 2248146-1997-00092
- Event Type
- Malfunction
- Date Received
- February 14, 1997
- Report Date
- January 17, 1997
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE FOLLOWING WAS REPORTED TO CO ON 1/17/97 VIA THE VOLUNTARY MEDWATCH FORM FROM THE FDA (TRIAGE UNIT SEQUENCE NUMBER 57295; MDR ACCESS NUMBER: 1010401). THE IAB RUPTURED. BLOOD BACKED UP INTO THE IAP PUMP. EVENT COMPLICATIONS: UNK-RPT'D 1/17/97. PT'S CURRENT STATUS: UNK -RPT'D 1/17/97.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERCOR STAT DL 9.5 FR. 34 CC IAB | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP. | 0684-00-0307 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |