FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO POWER SUPPLY
MDR report key: 1587651
·
Received January 20, 2010
Report
- Report Number
- 2242352-2009-00129
- Event Type
- Malfunction
- Date Received
- January 20, 2010
- Date of Event
- December 23, 2009
- Report Date
- December 24, 2009
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- HQO
- PMA / PMN Number
- K043155
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE TO PURSUE THE DEVICE BEING RETURNED TO CARDIAC SURGERY FOR INVESTIGATION WITH THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION COMPLETED. (B) (4)
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO POWER SUPPLY WAS INTERMITTENTLY WORKING. THE GREEN LIGHT ON THE BOTTOM DID NOT ALWAYS COME ON WHEN THE HEMOPRO AND THE POWER SUPPLY WERE PLUGGED IN. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT COMPLICATIONS. THE PRODUCT IS RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW HEMOPRO POWER SUPPLY | HEMOPRO SUPPLY | HQO | MAQUET CARDIOVASCULAR, LLC | VH-3010 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |