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 2020-03-24 for LUCEA ARD568601998 manufactured by Maquet Sas.
[185051526]
Issue is being investigated by manufacturer. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[185051527]
On (b)(6), 2019 getinge became aware of an issue with one of examination lights - lucea 40. Initial allegation was related with cover's cracks without indication of any missing particles, which was not considered as risk related issue. On-site inspection performed by getinge's technician on 4th march 2020 revealed that cracks on cover in this particular case led to missig particles. There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2020-00042 |
| MDR Report Key | 9871970 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-06-15 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Generic Name | DEVICE, MEDICAL EXAMINATION, AC POWERED |
| Product Code | KZF |
| Date Received | 2020-03-24 |
| Catalog Number | ARD568601998 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-24 |