FDA Adverse Event
Malfunction
Summary report: N
STAT DL 10.5 FR. 50 CC. IAB
MDR report key: 160533
·
Received March 30, 1998
Report
- Report Number
- 2248146-1998-00339
- Event Type
- Malfunction
- Date Received
- March 30, 1998
- Date of Event
- January 7, 1998
- Report Date
- March 18, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 7/2/98).
Description of Event or Problem · 1
THE IAB WAS INSERTED INTO THE PT ON 1/7/98 AT 4:00 PM. THE IAB LEAKED UPON INSERTION. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE PT. THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVAL. ON 6/11/98, THE FOLLOWING INFO WAS REPORTED TO DATASCOPE: A SUDDEN "GAS LOSS" ALARM SOUNDED FROM THE SYS 97 PUMP. THE IAB WAS DISCARDED BY THE FACILITY. (SEE 98-00796 FOR SECOND IAB). [EVENT COMPLICATIONS]: NONE FROM THE EVENT-REPORTED 3/18/98, 6/11/98. [PT'S CURRENT STATUS]: EXPIRED RPT'D 3/18/98.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAT DL 10.5 FR. 50 CC. IAB | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP. | 0684-00-0194 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |