FDA Adverse Event
Malfunction
Summary report: N
T.W. POWER SUPLPY
MDR report key: 2971373
·
Received February 4, 2013
Report
- Report Number
- 2242352-2013-00052
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Date of Event
- January 14, 2013
- Report Date
- January 14, 2013
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- HQO
- PMA / PMN Number
- K043155
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE POWER SUPPLY WAS OPERATING INTERMITTENTLY WHEN THE CABLE WAS PLACED IN CERTAIN POSITIONS. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47269 | T.W. POWER SUPLPY | ENDOSCOPIC VESSEL HARVESTING | HQO | MAQUET CARDIOVASCULAR, LLC | VH-3010 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |