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 2020-01-01 for T.W. POWER SUPPLY VH-3010 manufactured by Maquet Cardiovascular Llc.
[188691848]
Trackwise id# (b)(4). 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. Device discarded.
Patient Sequence No: 1, Text Type: N, H10
[188691849]
The hospital reported that during an endoscopic vein harvesting procedure, t. W. Power supply s/n (b)(4) warranty expired jul/09/19 stopped working (failed to deliver energy). A replacement device was used to complete the procedure. No patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242352-2020-00008 |
| MDR Report Key | 9537199 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-01 |
| Date of Report | 2019-12-31 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-01-01 |
| 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 |
| 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 | 2020-01-01 |
| Model Number | T.W. POWER SUPPLY |
| Catalog Number | VH-3010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-01 |