FDA Adverse Event
Malfunction
Summary report: N
STAT DL 9.5 FR. 40 CC. IAB
MDR report key: 173117
·
Received June 15, 1998
Report
- Report Number
- 2248146-1998-00650
- Event Type
- Malfunction
- Date Received
- June 15, 1998
- Report Date
- June 4, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSPITAL. (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 11/16/98).
Description of Event or Problem · 1
EVENT: (CC# 98-00685) THE WAVEFORM DAMPENED AND THE IAB WAS REMOVED. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-00683, 98-00684) ON 10/20/98, DATASCOPE WAS NOTIFIED THAT THE IAB WAS DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 6/4/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 6/4/98.
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 | UNKNOWN |