FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE
MDR report key: 3871939
·
Received April 17, 2014
Report
- Report Number
- 2249723-2014-00430
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- May 9, 2013
- Report Date
- May 9, 2013
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE OBSERVED AN "F0" ERROR CODE DISPLAYED ON THE EXECUTIVE BOARD. HE ALSO FOUND THAT THE DAUGHTER BOARD ON THE EXECUTIVE PROCESSOR BOARD WAS NOT FULLY SEATED. THE COMPANY REPRESENTATIVE RE-SEATED THE BOARD AND THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. FUNCTIONAL TESTING AND SAFETY CHECKS MET SPECIFICATIONS. (B)(4).
Description of Event or Problem · 1
DURING A ROUTINE CHECK OF THE IABP, THE COMPANY REPRESENTATIVE OBSERVED THAT UPON POWER-UP, THE IABP DISPLAYED "MAQUET" ON THE SCREEN. UNIT NEVER CONTINUED TO NORMAL MODE. UNIT POWERED UP IN SERVICE DIAGNOSTICS BUT NOT TOUCH SCREEN FUNCTION. NO PATIENT WAS INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236100 | CARDIOSAVE | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CARDIOSAVE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |