FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE
MDR report key: 3416721
·
Received September 30, 2013
Report
- Report Number
- 2249723-2013-00093
- Event Type
- Malfunction
- Date Received
- September 30, 2013
- Date of Event
- August 1, 2013
- Report Date
- August 1, 2013
- Manufacturer
- DATASCOPE CORP
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE REPLACED THE FRONT END PCB (PART NUMBER: 0670-00-0769). 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 PRIOR TO USE ON A PATIENT; THE IABP WOULD NOT START UP. THE IABP WAS DISPLAYING A SCROLLING ICON AND AN ALARM WAS GENERATED. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 493650 | CARDIOSAVE | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP | CARDIOSAVE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |