FDA Adverse Event
Malfunction
Summary report: N
CS100
MDR report key: 2862129
·
Received November 29, 2012
Report
- Report Number
- 2249723-2012-00444
- Event Type
- Malfunction
- Date Received
- November 29, 2012
- Date of Event
- October 14, 2012
- Report Date
- October 14, 2012
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OUR INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP GENERATED A "FAULT CODE #65" (SAFETY VENT FAILURE) ALARM, AND THE CONTROL KEYS WERE NOT WORKING. THE CUSTOMER RESET THE IABP. THE IABP THEN GENERATED A "SYSTEM FAILURE" ALARM AND WAS NOT FUNCTIONAL. 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 |
|---|---|---|---|---|---|---|---|
| 1 | CS100 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CS100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |