FDA Adverse Event
Malfunction
Summary report: N
PROFILE 8 FR. 40 CC. IAB WITH ACCESSORIES-DOMESTIC
MDR report key: 188701
·
Received September 23, 1998
Report
- Report Number
- 2248146-1998-01072
- Event Type
- Malfunction
- Date Received
- September 23, 1998
- Date of Event
- September 10, 1998
- Report Date
- September 14, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EVENT: (CC# 98-01146) THE 8 FR. IAB WOULD NOT INFLATE. ON 10/13/98, THE FOLLOWING WAS REPORTED: THE BALLOON WOULD NOT INFLATE AND IT WAS THEN REMOVED FROM THE BODY. THE PUMP ALARM SOUNDED AND THERE WAS NO AUGMENTATION. ANOTHER IAB WAS INSERTED POST CABG BY THE SURGEON. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/14/98; NONE - RPT'D 10/13/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 9/14/98.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFILE 8 FR. 40 CC. IAB WITH ACCESSORIES-DOMESTIC | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP. | 0884-00-0009 | 08/15/00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |