FDA Adverse Event
Malfunction
Summary report: N
CS300
MDR report key: 4063318
·
Received August 8, 2014
Report
- Report Number
- 2249723-2014-01198
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- August 30, 2012
- Report Date
- August 30, 2012
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K062525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE PERFORMED A VOLUME TEST IN DIAGNOSTIC MODE AND THE TEST FAILED. IT WAS SUSPECTED THAT THE VOLUME CYLINDER WAS OUT OF ORDER WHEN FILLING. THE COMPANY REPRESENTATIVE REPLACED THE HELIUM VOLUME CYLINDER (P/N: 0202-00-0133). 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 COMPANY REPRESENTATIVE REPORTED THAT AT THE START-UP THE IABP GENERATED AN "AUTO FILL FAILURE" ALARM. NO PATIENT WAS INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472825 | CS300 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CS300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |