FDA Adverse Event
Malfunction
Summary report: N
T.W. POWER SUPPLY
MDR report key: 3855717
·
Received April 21, 2014
Report
- Report Number
- 2242352-2014-00462
- Event Type
- Malfunction
- Date Received
- April 21, 2014
- Date of Event
- March 27, 2014
- Report Date
- March 28, 2014
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC.
- Product Code
- HQO
- PMA / PMN Number
- K043155
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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. SINCE THIS IS AN OEM SUPPLIED DEVICE, A LOT HISTORY REVIEW IS NOT APPLICABLE. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE POWER WAS INTERMITTENT ON THE T.W. POWER SUPPLY. IT WOULD NOT WORK ON A CONTINUAL BASIS. A REPLACEMENT 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 |
|---|---|---|---|---|---|---|---|
| 241577 | T.W. POWER SUPPLY | POWER SUPPLY | HQO | MAQUET CARDIOVASCULAR, LLC. | VH-3010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |