MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-06 for MAQUET SAS PWD 700 DF 568370903 manufactured by Maquet Sas.
[3455735]
Customer informed maquet that an ambient light module had detached from a surgical cupola during a surgery. No injuries were reported. The module remained attached to wires and secured to light. (b)(4). Please refer mfr report # 9710055-2013-00021.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008355164-2013-00108 |
| MDR Report Key | 3115316 |
| Date Received | 2013-05-06 |
| Date of Report | 2013-04-11 |
| Date of Event | 2013-04-11 |
| Date Facility Aware | 2013-04-11 |
| Report Date | 2013-05-06 |
| Date Added to Maude | 2013-05-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 074700000 |
| Manufacturer Country | US |
| Manufacturer Postal | 074700000 |
| Manufacturer G1 | MAQUET MEDICAL SYSTEMS USA |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 0000 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAQUET SAS |
| Generic Name | NA |
| Product Code | NTN |
| Date Received | 2013-05-06 |
| Model Number | PWD 700 DF |
| Catalog Number | 568370903 |
| Lot Number | NA |
| ID Number | 568301037 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET SAS |
| Manufacturer Address | ORLEANS FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-06 |