FDA Adverse Event
Malfunction
Summary report: N
CS100
MDR report key: 2862132
·
Received November 29, 2012
Report
- Report Number
- 2249723-2012-00381
- Event Type
- Malfunction
- Date Received
- November 29, 2012
- Date of Event
- September 13, 2012
- Report Date
- September 13, 2012
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE REPLACED THE POWER SUPPLY (PART NUMBER 0014-00-0033E05). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP DISPLAYED "BATTERY IN USE" WHEN PLUGGED INTO AC OUTLET. WHEN THEY ATTEMPTED TO TRANSPORT THE PT, THE IABP GENERATED A "SYSTEM FAILURE" ALARM AND SHUTDOWN. 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 |
|---|---|---|---|---|---|---|---|
| 1 | CS100 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CS100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |