MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-20 for ILED7 4068120 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[128567483]
During inspection, the technician found that the light was improperly assembled. The root cause was the improper installation of the stop screw. The screw was adjusted and device is functioning as designed. The mobile stand version has a high tilting stability. The following, basic precautions must be considered when positioning the mobile stand version. The stand might tilt when the rollers are locked and excessive force is exerted onto the spring arm or light head. User should avoid strong leverage onto the spring arm or the light head and not add additional loads to the spring arm.
Patient Sequence No: 1, Text Type: N, H10
[128567484]
During articulation, the spring arm rotated past its intended stop and the mobile light tipped. No patient or caregiver injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2018-00069 |
| MDR Report Key | 8090346 |
| Date Received | 2018-11-20 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-10-24 |
| Date Mfgr Received | 2018-10-24 |
| Device Manufacturer Date | 2016-01-15 |
| Date Added to Maude | 2018-11-20 |
| 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. STEFFEN ULBRICH |
| Manufacturer Street | CARL-ZEISS STRASSE 7-9 |
| Manufacturer City | SAALFELD, 07318 |
| Manufacturer Country | GM |
| Manufacturer Postal | 07318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ILED7 |
| Generic Name | MOBILE LIGHT |
| Product Code | FSQ |
| Date Received | 2018-11-20 |
| Model Number | 4068120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRUMPF MEDIZIN SYSTEME GMBH + CO. KG |
| Manufacturer Address | CARL-ZEISS STRASSE 7-9 SAALFELD, 07318 GM 07318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-20 |