MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-16 for T.W. POWER SUPPLY C-VH-3010 manufactured by Maquet Cardiovascular Llc.
[145290854]
(b)(4). The device has been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[145290855]
The hospital reported that during an endoscopic vein harvesting procedure, t. W. Power supply s/n (b)(4) was not powering on. A replacement device was used to complete the procedure. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242352-2019-00573 |
| MDR Report Key | 8617232 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-08-09 |
| Device Manufacturer Date | 2018-06-29 |
| Date Added to Maude | 2019-05-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer G1 | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T.W. POWER SUPPLY |
| Generic Name | UNIT, CAUTERY, THERMAL, AC-POWERED |
| Product Code | HQO |
| Date Received | 2019-05-16 |
| Returned To Mfg | 2019-05-01 |
| Catalog Number | C-VH-3010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Address | 45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |