FDA Adverse Event
Malfunction
Summary report: N
T.W. POWER SUPPLY
MDR report key: 3021009
·
Received March 20, 2013
Report
- Report Number
- 2242352-2013-00261
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- January 29, 2013
- Report Date
- February 28, 2013
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- HQO
- PMA / PMN Number
- K043155
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).
Description of Event or Problem · 1
THE HOSP REPORTED THAT THE T.W. POWER SUPPLY FAILED TO DELIVER ENERGY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE HOSP WILL REPORTEDLY NOT BE RETURNING THE PRODUCT IN QUESTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115589 | T.W. POWER SUPPLY | ENDOSCOPIC VESSEL HARVESTING | HQO | MAQUET CARDIOVASCULAR, LLC | VH-3010 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |