MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-04 for ILED 1537476 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[96623725]
It is known that improper installation, maintenance or a collision can lead to the spring arm cover falling off. The device was evaluated and repaired by a trumpf medical (b)(4) distributor.
Patient Sequence No: 1, Text Type: N, H10
[96623726]
The plastic cover on an ondal spring arm attached to the trumpf medical surgical light detached and fell above the operating field. It did not fall into the sterile field and no patient injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2018-00003 |
| MDR Report Key | 7165398 |
| Date Received | 2018-01-04 |
| Date of Report | 2017-12-08 |
| Date of Event | 2017-12-08 |
| Date Mfgr Received | 2017-12-08 |
| Device Manufacturer Date | 2012-06-18 |
| Date Added to Maude | 2018-01-04 |
| 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, SAALE 07318 |
| Manufacturer Country | GM |
| Manufacturer Postal | 07318 |
| Manufacturer G1 | TRUMPF MEDIZIN SYSTEME GMBH + CO. KG |
| Manufacturer Street | CARL-ZEISS STRASSE 7-9 |
| Manufacturer City | 07318 SAALFELD, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ILED |
| Generic Name | ILED 3 |
| Product Code | FQP |
| Date Received | 2018-01-04 |
| Model Number | 1537476 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRUMPF MEDIZIN SYSTEME GMBH + CO. KG |
| Manufacturer Address | CARL-ZEISS STRASSE 7-9 07318 SAALFELD, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-04 |