FDA Adverse Event
Malfunction
Summary report: N
CS300
MDR report key: 3031023
·
Received March 28, 2013
Report
- Report Number
- 2249723-2013-00025
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Date of Event
- February 18, 2013
- Report Date
- February 18, 2013
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP REPLACED THE MOTOR CONTROLLER PCB (PART NUMBER (B)(4)). IN UNRELATED REPAIRS, THE FILTER TUBING AND THE EXPIRED SAFETY DISK WERE ALSO REPLACED. THE IABP WAS TESTED TO FACTOR SPECIFICATION. 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 GENERATED A "LOW VACUUM" ALARM AND SHUT DOWN. 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 |
|---|---|---|---|---|---|---|---|
| 129665 | CS300 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CS300 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |