MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-17 for ILED ILED3K 1537478 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[68012981]
The affective lamp body was replaced. The defective parts were returned to trumpf medical for examination.
Patient Sequence No: 1, Text Type: N, H10
[68012982]
During preventative maintenance of the iled 3k, peeling paint was discovered on the unit's lamp head. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
[74536021]
The affected device was replaced at the facility. The returned, defective parts were investigated and evaluated. Our investigation has identified steps in the manufacturing process which combined with non-approved cleaners can lead to the paint chipping. The damage to the painted surfaces usually does not develop suddenly, but develops over time. The instructions for use state that the devices must be checked for proper condition prior to each use. Damaged devices must not be used. If damage to the surface coating is recognized and removed, there is no danger to the patient. The surface coating process will be updated to include additional testing and verification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681407-2017-00007 |
| MDR Report Key | 6339587 |
| Date Received | 2017-02-17 |
| Date of Report | 2017-01-19 |
| Date of Event | 2017-01-19 |
| Device Manufacturer Date | 2010-10-12 |
| Date Added to Maude | 2017-02-17 |
| 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 | SERVICE PERSONNEL |
| 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 |
| Manufacturer Phone | 6715864140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ILED |
| Generic Name | ILED 3 LAMP, OPERATING-ROOM |
| Product Code | FQP |
| Date Received | 2017-02-17 |
| Model Number | ILED3K |
| Catalog Number | 1537478 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-02-17 |