FDA Adverse Event
Malfunction
Summary report: N
STAT DL 9.5 FR. 40 CC. IAB
MDR report key: 182339
·
Received August 11, 1998
Report
- Report Number
- 2248146-1998-00892
- Event Type
- Malfunction
- Date Received
- August 11, 1998
- Report Date
- July 29, 1998
- Manufacturer
- DATASCOPE CORPORATION
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
EVENT: (CC# 98-00943) THE IAB LEAKED. SPECS WERE NOTED IN THE TUBING AND THE IAB WAS REMOVED. ON 3/15/99, DATASCOPE WAS NOTIFIED THAT THE IAB WAS DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 7/29/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 7/29/98.
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 CORPORATION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |