T.W. POWER SUPPLY
Report
- Report Number
- 2242352-2024-0001282
- Event Type
- Malfunction
- Date Received
- November 22, 2024
- Report Date
- January 17, 2025
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- GEI
- UDI-DI
- 00607567700826
- PMA / PMN Number
- K052274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
TRACKWISE ID# (B)(4). COMPLAINT BEING CANCELLED DUE TO ADDITIONAL INFORMATION RECEIVED INDICATES THERE WERE NO DEFECTS WITH THE REPORTED DEVICE. PER THE COMPLAINT HANDLING PROCEDURE THE INFORMATION RECEIVED DOES NOT MEET THE CRITERIA OF A COMPLAINT. PLEASE REDACT MFG REPORT NUMBER 2242352-2024-0001282.
TRACKWISE ID# (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.
COMPLAINT BEING CANCELLED DUE TO ADDITIONAL INFORMATION RECEIVED INDICATES THERE WERE NO DEFECTS WITH THE REPORTED DEVICE. PER THE COMPLAINT HANDLING PROCEDURE THE INFORMATION RECEIVED DOES NOT MEET THE CRITERIA OF A COMPLAINT. PLEASE REDACT MFG REPORT NUMBER 2242352-2024-0001282.
THE HOSPITAL REPORTED THAT T.W. POWER SUPPLY WAS DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2599212 | T.W. POWER SUPPLY | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MAQUET CARDIOVASCULAR LLC | VH-3010 | 00607567700826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |