FDA Adverse Event
Malfunction
Summary report: N
CS300
MDR report key: 4122473
·
Received September 22, 2014
Report
- Report Number
- 2249723-2014-01393
- Event Type
- Malfunction
- Date Received
- September 22, 2014
- Date of Event
- April 9, 2013
- Report Date
- April 10, 2013
- Manufacturer
- DATASCOPE CORP.,
- Product Code
- DSP
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP REVIEWED THE ERROR CODES IN THE LOGS OF THE UNIT. TRANSDUCERS AND DRIVE ASSEMBLY BOTH CHECKED OUT OKAY. THE COMPANY REP REPLACED THE FRONT END CIRCUIT BOARD (B)(4), DUE TO CORROSION ON SEVERAL COMPONENTS, WHICH WAS RELATED TO A SALINE SPILL THAT OCCURRED AT AN EARLIER DATE. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, UPON START-UP OF THE UNIT, THEY RECEIVED AN ELECTRICAL TEST FAILURE CODE #52 (SHUTTLE TRANSDUCER OFFSET FAILURE). NO PT WAS INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 587508 | CS300 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP., | CS300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |