FDA Adverse Event
Malfunction
Summary report: N
CS300
MDR report key: 3031004
·
Received March 28, 2013
Report
- Report Number
- 2249723-2013-00029
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Date of Event
- February 23, 2013
- Report Date
- February 23, 2012
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE REPLACED THE FRONT END BOARD (PART NUMBER (B)(4)). THE SYSTEM WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP GENERATED "ERROR CODE 119" (FRONT END CPU FAILURE). THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127808 | CS300 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CS300 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |