FDA Adverse Event
Malfunction
Summary report: N
CS300
MDR report key: 2961197
·
Received January 30, 2013
Report
- Report Number
- 2249723-2013-00005
- Event Type
- Malfunction
- Date Received
- January 30, 2013
- Date of Event
- December 4, 2012
- Report Date
- December 5, 2012
- Manufacturer
- DATASCOPE CORP
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER TESTED THE BATTERY RUN TIME AND OBSERVED THE IABP RAN FOR 70 MINUTES. THE "LOW BATTERY" ALARM FUNCTIONED NORMALLY. THE BATTERIES SHOULD BE REPLACED WHEN RUNTIME IS LESS THAN 135 MINUTES. HE ELECTED TO REPLACE THE BATTERIES WITHOUT ASSISTANCE FROM MAQUET. THE BATTERIES WERE DISCARDED BY THE CUSTOMER AND ARE THEREFORE NOT AVAILABLE FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, AFTER TRANSPORT AND BEFORE THE IABP WAS CONNECTED TO AC POWER, THE IABP SHUTDOWN WITHOUT A "LOW BATTERY" ALARM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39982 | CS300 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP | CS300 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |