FDA Adverse Event
Malfunction
Summary report: N
CS100
MDR report key: 1182315
·
Received September 30, 2008
Report
- Report Number
- 2221819-2008-00047
- Event Type
- Malfunction
- Date Received
- September 30, 2008
- Date of Event
- August 21, 2008
- Report Date
- August 21, 2008
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE OBSERVED THAT THE SYSTEM ERROR LOG CONTAINED AN ELECTRICAL TEST FAILURE CODE 65 (SAFETY VENT FAILURE). HE REPLACED THE SAFETY VENT SOLENOID VALVE. HE WAS NOT ABLE TO VERIFY THE REPORTED AUTOFILL FAILURES. IN AN UNRELATED REPAIR, HE REPLACED A GLASS PIPETTE ASSEMBLY THAT HAD A FOGGY APPEARANCE. THE UNIT WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, THE UNIT GENERATED A "SYSTEM CHECK FAILURE" ERROR MESSAGE, AUTOFILL FAILURE MESSAGES, AND THEN IT 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 | CS100 | IABP | DSP | DATASCOPE CORP. | CS100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |