FDA Adverse Event
Malfunction
Summary report: N
CS300
MDR report key: 3261768
·
Received July 30, 2013
Report
- Report Number
- 2249723-2013-00070
- Event Type
- Malfunction
- Date Received
- July 30, 2013
- Date of Event
- June 18, 2013
- Report Date
- June 18, 2013
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. HE OBSERVED A WORN CABLE ON THE DISPLAY HEAD, SO AS A PRECAUTIONARY MEASURE, THE COILED CABLE (PART NUMBER 0012-00-1422) WAS REPLACED. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PT, UPON POWER-UP OF THE IABP, THE DISPLAY SCREEN STARTED TO FLICKER. THE IABP WAS REPLACED AND THERAPY WAS INITIATED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 356430 | CS300 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CS300 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |