FDA Adverse Event
Malfunction
Summary report: N
CS300
MDR report key: 2961167
·
Received January 30, 2013
Report
- Report Number
- 2249723-2013-00008
- Event Type
- Malfunction
- Date Received
- January 30, 2013
- Date of Event
- December 9, 2012
- Report Date
- December 10, 2012
- Manufacturer
- DATASCOPE CORP
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE REPLACED THE PRESSURE TRANSDUCER (PART NUMBER: 0682-00-0076-01). 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, AFTER THREE DAYS OF THERAPY, THE IABP GENERATED AN "AUTOFILL FAILURE" ALARM AND THE IABP STOPPED PUMPING. THE CUSTOMER PUSHED THE "IAB FILL" KEY AND TRIED TO REFILL THE IABP SEVERAL TIMES, BUT THEY WERE UNABLE TO FILL THE IAB. THE CUSTOMER RECYCLED POWER TO THE IABP TWO TIMES; HOWEVER, BOTH TIME IT GENERATED AN "ELECTRICAL TEST FAILURE CODE #53" ALARM (SHUTTLE TRANSDUCER OFFSET FAILURE). 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 |
|---|---|---|---|---|---|---|---|
| 40120 | CS300 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP | CS300 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |