FDA Adverse Event
Malfunction
Summary report: N
CS100
MDR report key: 3874788
·
Received April 25, 2014
Report
- Report Number
- 2249723-2014-00519
- Event Type
- Malfunction
- Date Received
- April 25, 2014
- Date of Event
- September 24, 2013
- Report Date
- September 24, 2013
- Manufacturer
- DATASCOPE CORP
- Product Code
- DSP
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MAQUET REPRESENTATIVE REPLACED THE EXTERNAL OUTPUT CABLE ASSEMBLY (PART NUMBER 0012-00-0765) ON (B)(4), 2013. AFTER THE REPLACEMENT, THE CALIBRATION WAS PERFORMED. THE FUNCTIONAL TESTING AND SAFETY CHECK TO FACTORY SPECIFICATIONS AND THE DEVICE IS FULLY OPERATIONAL. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THEY FOUND THE JACK FOR ECG MONITOR INPUT WAS LOOSE. 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 |
|---|---|---|---|---|---|---|---|
| 250792 | CS100 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP | CS100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |