FDA Adverse Event
Malfunction
Summary report: N
STAT DL 9.5 FR. 40 CC. IAB
MDR report key: 172989
·
Received June 15, 1998
Report
- Report Number
- 2248146-1998-00656
- Event Type
- Malfunction
- Date Received
- June 15, 1998
- Date of Event
- June 5, 1998
- Report Date
- June 5, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
EVENT: (CC# 98-00691) AFTER IABP FOR ABOUT 30 MINUTES, THE IAB LEAKED. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE PATIENT. ON 1/26/99, DATASCOPE WAS NOTIFIED THAT THE IAB WAS DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. [EVENT COMPLICATION]: NONE FROM THE EVENT - REPORTED 6/5/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 6/5/98.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAT DL 9.5 FR. 40 CC. IAB | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP. | 0684-00-0306 | 05/01/00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |