FDA Adverse Event
Malfunction
Summary report: N
TW POWER SUPPLY, US
MDR report key: 2442203
·
Received January 24, 2012
Report
- Report Number
- 2242352-2012-00087
- Event Type
- Malfunction
- Date Received
- January 24, 2012
- Report Date
- January 21, 2012
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- HQO
- PMA / PMN Number
- K043155
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. ITEMS MARKED "NI" ARE UNKNOWN TO US AT THIS TIME. INTERNAL FILE NUMBER - (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. THEY PLUGGED THE POWER SUPPLY INTO A DIFFERENT OUTLET BUT IT STILL DID NOT WORK. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. 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 |