MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-26 for LUCEA 40 ARD568601997 manufactured by Maquet Sas.
[187256021]
Additional information will be provided upon results of investigation. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[187256022]
On (b)(6) 2019 getinge became aware of an issue with one of the light? Lucea. As it was stated the plastic casing of the lucea was cracked and due to this was removed from the room. Customer did not provide any information about any parts falling down however on the provided photographic evidence lack of some particles was noticed, therefore we could suspected that some of them potentially fell down. Taking under consideration collected up to date information we decided to report this case based on potential as any parts falling from the device might cause contamination. Manufacturer's reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2020-00070 |
| MDR Report Key | 9886488 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2019-03-12 |
| Date Added to Maude | 2020-03-26 |
| 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 40 |
| Generic Name | DEVICE, MEDICAL EXAMINATION, AC POWERED |
| Product Code | KZF |
| Date Received | 2020-03-26 |
| Catalog Number | ARD568601997 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-26 |