FDA Adverse Event
Malfunction
Summary report: N
TW POWER SUPPLY, US
MDR report key: 2442128
·
Received January 24, 2012
Report
- Report Number
- 2242352-2012-00079
- Event Type
- Malfunction
- Date Received
- January 24, 2012
- Date of Event
- January 20, 2012
- Report Date
- January 20, 2012
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- HQO
- PMA / PMN Number
- K043155
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE POWER SUPPLY WOULD NOT POWER UP. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. MAQUET CARDIOVASCULAR ANTICIPATES THE RETURN OF THE PRODUCT IN QUESTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TW POWER SUPPLY, US | ENDOSCOPIC VESSEL HARVESTING | HQO | MAQUET CARDIOVASCULAR, LLC | VH-3010 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |