FDA Adverse Event
Malfunction
Summary report: N
STAT DL 10.5 FR. 50 CC. IAB
MDR report key: 184739
·
Received August 27, 1998
Report
- Report Number
- 2248146-1998-00963
- Event Type
- Malfunction
- Date Received
- August 27, 1998
- Date of Event
- August 15, 1998
- Report Date
- August 17, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EVENT: (CC# 98-01024) THE IAB LEAKED. THIS WAS THE ONLY INFORMATION AT THE TIME OF THE REPORT. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 9/17/98: THE IAB LEAKED AFTER 5 HOURS. THE ALARM SOUNDED FROM THE PUMP. THE IAB WAS INSERTED ON 8/15/98 AND WAS REMOVED ON 8/15/98. ANOTHER WAS INSERTED. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT ON 8/15/98. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-01245). [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 8/17/98; NONE - RPT'D 9/17/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 8/17/98.
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 | 05/23/00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |