FDA Adverse Event
Malfunction
Summary report: N
CS100
MDR report key: 3031024
·
Received March 28, 2013
Report
- Report Number
- 2249723-2013-00024
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 4, 2013
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP EVALUATED THE IABP, WHICH WAS MANUFACTURED IN 2003. HE REPLACED THE DISPLAY (PART NUMBER (B)(4)), THE VIDEO RECEIVER TO LCD CABLE (PART NUMBER (B)(4)), AND THE BACKLIGHT INVERTER PRINTED CIRCUIT BOARD (PART NUMBER (B)(4)). THE IABP 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 PT, THE IABP SCREEN WENT BLANK. THE ASSIST FUNCTION REMAINED OPERATIONAL. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128692 | CS100 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CS300 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |