FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 98
MDR report key: 2072832
·
Received March 31, 2011
Report
- Report Number
- 2249723-2011-00023
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Date of Event
- January 29, 2011
- Report Date
- February 3, 2011
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ADD'L INFO REGARDING THE INCIDENT WAS PROVIDED BY MAQUET (B)(4) AT THIS TIME. DATASCOPE (B)(4) WILL FILE A F/U REPORT AS SOON AS THE INVESTIGATION INFO IS AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, THE UNIT ALARMED, AND DISPLAYED A "RAPID GAS LOSS" MESSAGE. THE PT WAS SWITCHED TO ANOTHER UNIT AND THERAPY WAS CONTINUED. SEVERAL DAYS LATER, WHILE THE UNIT WAS IN USE ON A PT, THE UNIT SHUT DOWN. THE PT WAS SWITCHED TO ANOTHER UNIT AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 98 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | SYSTEM 98 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |