MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-21 for LUCEA LED LCA50 MOBILE B LCA309005C manufactured by Maquet Sas.
[29256684]
(b)(6) 2015 09:12 am (gmt-4:00) added by (b)(6) ((b)(4)): a maquet field service technician evaluated the device and found that the root cause of this incident was a missing bolt. The bolt that holds the main pole to the wheels assembly could not be located after the event. However, scuff marks in the steel prove that the missing part was there initially. It has not been determined why the bolt was missing. The lucea led operating manual includes instructions to check annually that all retaining screws and all visible screws of the shaft and the arm are tightly fixed. Additionally, the users are warned that the light could fall over, and are requested to take care when moving the mobile stand. Component codes: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[29256705]
The customer reported to maquet service that a part of a mobile surgical light disconnected during surgery when the or technician attempted to move it. When trying to prevent the light from falling to the floor, she was hit on the right shoulder. No information was provided regarding the outcome of the technician. No injury to patient was reported. Factory reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2015-01020 |
| MDR Report Key | 5166933 |
| Date Received | 2015-10-21 |
| Date of Report | 2015-09-23 |
| Date of Event | 2015-09-23 |
| Date Mfgr Received | 2015-09-23 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2015-10-21 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PARC DE LIM AVENUE DE LA POMME DE PI |
| Manufacturer City | ORL 45074 |
| Manufacturer Country | FR |
| Manufacturer Postal | 45074 |
| Manufacturer G1 | MARIE-FRAN |
| Manufacturer Street | PARC DE LIM AVENUE DE LA POMME DE PI |
| Manufacturer City | ORL 45074 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 45074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LUCEA LED |
| Generic Name | LIGHT, SURGICAL, FLOOR STANDING |
| Product Code | FSS |
| Date Received | 2015-10-21 |
| Model Number | LCA50 MOBILE B |
| Catalog Number | LCA309005C |
| ID Number | 568604977 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET SAS |
| Manufacturer Address | ORL?ANS CEDEX 2 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-21 |