MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-06 for LUCEA 10 ARD568602971 manufactured by Maquet Sas.
[178210043]
The issue is being investigated by manufacturing site. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[178210044]
On (b)(6) 2019 getinge became aware of an issue with lucea 10 light. As it was stated, the connection between main tube and suspension arm was cracked. There was no injury reported. Taking into consideration the worst case scenario which is the detachment of examination light, we decided to report the issue based on the potential.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2019-00354 |
| MDR Report Key | 9423927 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-06 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-11-11 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-06-19 |
| Date Added to Maude | 2019-12-06 |
| 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 Contact | MR. PASCAL JAY |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Manufacturer G1 | MAQUET SAS |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUCEA 10 |
| Generic Name | DEVICE, MEDICAL EXAMINATION, AC POWERED |
| Product Code | KZF |
| Date Received | 2019-12-06 |
| Model Number | ARD568602971 |
| Catalog Number | ARD568602971 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET SAS |
| Manufacturer Address | PARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-06 |