FDA Adverse Event
Malfunction
Summary report: N
STAT DL 9.5 FR. 40 CC. IAB
MDR report key: 189934
·
Received September 29, 1998
Report
- Report Number
- 2248146-1998-01102
- Event Type
- Malfunction
- Date Received
- September 29, 1998
- Report Date
- September 18, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
EVENT: (CC# 98-01182) THE IAB WAS INSERTED INTO THE PATIENT VIA A CUTDOWN. THE "SLOW GAS" ALARM SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE TUBING. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE PATIENT. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-01183) THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/18/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 9/18/98.
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. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |