FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE
MDR report key: 4001888
·
Received June 10, 2014
Report
- Report Number
- 2249723-2014-00537
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- September 12, 2012
- Report Date
- September 12, 2012
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP OBSERVED MANY LOG ERROR CODE 37S 'FILL FAIL-SHUTTLE PURGE TIME OUT' AND 'DEAD VOLUME CALC. TIMEOUT'. THE COMPANY REP CONFIRMED THAT THE PIM CONNECTOR WAS OK AND PERFORMED A LEAK TEST AND THERE WAS NO ERROR AND THE CARDIOSAVE WORKED WELL. SUBSEQUENTLY THE CARDIOSAVE PERIODICALLY DISPLAYED AN 'AUTOFILL' ERROR MESSAGE DURING THE FIRST AUTOFILLS. AS A PRECAUTIONARY MEASURE, THE COMPANY REP REPLACED THE PNEUMATIC INTERFACE MOD ASSEMBLY (PART NUMBER 0997-00-0582. (B)(4).
Description of Event or Problem · 1
THE COMPANY REP, DURING A ROUTINE CHECK, OBSERVED THAT THE IABP GENERATED A "AUTO FILL ERROR". NO PT WAS INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 337151 | CARDIOSAVE | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CARDIOSAVE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |