MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-19 for ILED 7 4047020 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[114801341]
The lamp head is secured to the spring arm by a retaining segment which is maintained in place by a safety sleeve that is held over the segment with a set screw. The root cause for this incident has been determined as a missing set screw that allowed the safety sleeve to move out of place and the retaining segment to migrate out. The service history of the device was reviewed and revealed no servicing activity performed by trumpf medical that would have any impact on this connection. The account's biomedical staff reassembled the lamp head after the fall and a trumpf medical service technician completed an inspection and functions check of the system the same day. All of the facility's light systems have been evaluated for the same condition and no other issues were identified.
Patient Sequence No: 1, Text Type: N, H10
[114801342]
As the hospital staff was cleaning the light system, the lamp head of a trumpf medical surgical light separated at the cardanic - spring arm joint then fell. The lamp head dropped a short distance landing directly on an or table top. No one was injured as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2018-00035 |
| MDR Report Key | 7702440 |
| Date Received | 2018-07-19 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-06-21 |
| Date Mfgr Received | 2018-06-22 |
| Device Manufacturer Date | 2017-05-18 |
| Date Added to Maude | 2018-07-19 |
| 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 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 | ILED 7 |
| Generic Name | SURGICAL LIGHT |
| Product Code | FQP |
| Date Received | 2018-07-19 |
| Model Number | 4047020 |
| 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 | 2018-07-19 |