FDA Adverse Event
Malfunction
Summary report: N
CS100
MDR report key: 2961199
·
Received January 30, 2013
Report
- Report Number
- 2249723-2013-00004
- Event Type
- Malfunction
- Date Received
- January 30, 2013
- Date of Event
- November 29, 2012
- Report Date
- November 29, 2012
- Manufacturer
- DATASCOPE CORP
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE REPLACED THE BATTERIES (PART NUMBER 0146-00-0039). IN AN UNRELATED REPAIR, THE ECG PT CABLE WAS REPLACED, ALONG WITH THE ECG SNAP LEAD WIRES. THE IABP WAS TESTED TO FACTORY 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 DURING TRANSPORT, THE IABP LOST BATTERY POWER AND SHUTDOWN AFTER APPROXIMATELY 50 MINUTES. THE IABP WAS PLUGGED INTO AN INVERTER ON THE HELICOPTER AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41637 | CS100 | INTER-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP | CS100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |