FDA Adverse Event
Malfunction
Summary report: N
CS100
MDR report key: 2072830
·
Received March 31, 2011
Report
- Report Number
- 2249723-2011-00007
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Date of Event
- January 31, 2011
- Report Date
- February 1, 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 USA WILL FILE A F/U REPORT AS SOON AS THE INVESTIGATION INFO IS AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AFTER INITIATING THERAPY, THE UNIT SHUTDOWN ALMOST IMMEDIATELY WITHOUT ALARM. THE CUSTOMER RESTARTED THE UNIT AND THE UNIT STARTED TO PUMP. HOWEVER, 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 | CS100 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CS100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |