FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO TW POWER SUPPLY, US
MDR report key: 1648767
·
Received March 26, 2010
Report
- Report Number
- 2242352-2010-00842
- Event Type
- Malfunction
- Date Received
- March 26, 2010
- Date of Event
- February 25, 2010
- Report Date
- February 25, 2010
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- HQO
- PMA / PMN Number
- K043155
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO CARDIAC SURGERY ON (B) (6) 2010, FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B) (4)
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO POWER SUPPLY DID NOT WORK. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW HEMOPRO TW POWER SUPPLY, US | POWER SUPPLY | HQO | BOSTON SCIENTIFIC CORPORATION | VH-3010 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |