FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID TYPE B PLUG
MDR report key: 3416746
·
Received September 30, 2013
Report
- Report Number
- 2249723-2013-00082
- Event Type
- Malfunction
- Date Received
- September 30, 2013
- Date of Event
- July 16, 2013
- Report Date
- July 17, 2013
- Manufacturer
- DATASCOPE CORP
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE VERIFIED THE COMMUNICATION ERRORS IN THE LOGS. HE REPLACED THE FRONT END PCB (PART NUMBER: 0670-00-0769). IN AN UNRELATED SERVICE ACTIVITY, THE SOFTWARE WAS UPGRADED TO THE LATEST REVISION. 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 UNIT ALARMED :INTERNAL COMMUNICATION FAILURE" AND STOPPED PUMPING. 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 |
|---|---|---|---|---|---|---|---|
| 493663 | CARDIOSAVE HYBRID TYPE B PLUG | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP | CARDIOSAVE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |