FDA Adverse Event
Death
Summary report: N
STAT DL 9.5 FR. 34 CC. IAB, ALT B
MDR report key: 209985
·
Received February 12, 1999
Report
- Report Number
- 2248146-1999-00010
- Event Type
- Death
- Date Received
- February 12, 1999
- Date of Event
- January 27, 1999
- Report Date
- February 10, 1999
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE INTRA-AROTIC BALLOON WAS INSERTED INTO THE PT ON 1/25/99. ON 1/27/99, "CHECK INTRA-AORTIC BALLOON" ALARM SOUNDED AGAIN AND AGAIN FROM THE SYSTEM 97 PUMP. THE PT'S BLOOD PRESSURE WAS ABOUT 100MMHG AND THE HEART RATE WAS ABOUT 120BPM. THE PT WENT ON TO EXPIRE ON 1/28/99. (EVENT COMPLICATIONS: THE PT EXPIRED - REPORTED 2/10/99.) (PT'S CURRENT STATUS: EXPIRED - REPORTED 2/10/99.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAT DL 9.5 FR. 34 CC. IAB, ALT B | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP. | 0784-00-0139 | 09/20/00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Death |