FDA Adverse Event
Malfunction
Summary report: N
CS300
MDR report key: 2072835
·
Received March 31, 2011
Report
- Report Number
- 2249723-2011-00032
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 14, 2011
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE COMPANY REP FOUND MULTIPLE FAULTS AND ALARMS IN THE FAULT JOURNAL INCLUDING AN IABP SHUTDOWN. THE COMPANY REP REPLACED THE MAIN BOARD ((B)(4)). THE UNIT WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. A REVIEW OF THE IABP'S SERVICE HISTORY DOES NOT INDICATE ANY SYSTEMIC ISSUES.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PATIENT, THE UNIT SHUTDOWN AND GENERATED THE "ELECTRICAL TEST FAILS CODE #52". NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CS300 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CS300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |