FDA Adverse Event
Malfunction
Summary report: N
STAT DL 9.5 FR. 34 CC. IAB
MDR report key: 188256
·
Received September 16, 1998
Report
- Report Number
- 2248146-1998-01031
- Event Type
- Malfunction
- Date Received
- September 16, 1998
- Report Date
- September 1, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EVENT: (CC# 98-01106) THE IAB LEAKED DURING INSERTION. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE PATIENT. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-01107). ON 3/15/99, DATASCOPE WAS NOTIFIED THAT THE IAB WAS DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/1/98. [PATIENT'S CURRENT STATUS]: UNK -RPT'D 9/1/98.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAT DL 9.5 FR. 34 CC. IAB | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP. | 0684-00-0206-01 | 06/12/00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |