MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-16 for TRULIGHT DUO 1574850 manufactured by Trumpf Medizin Systeme Gmbh + Co. Kg.
[117451478]
The account's technician received a request to adjust the light due to a drifting light head. While adjusting the light, the spring arm separated from the central axis, knocking the account's technician from his ladder to the floor. The light struck him and he suffered a laceration above his eye that required six stitches. He also struck his head on the floor then underwent a ct scan and x-ray. He was later diagnosed with a concussion and placed on light duty restriction at work. The hill-rom field service technician confirmed the narrative given by the account's technician. He found the failure was likely due to the improper installation of the snap ring at the spring arm - central axis joint. The snap ring will be replaced once the replacement parts arrive.
Patient Sequence No: 1, Text Type: N, H10
[117451479]
Hill-rom received a report from the account stating the spring arm separated from the central axis, fell and struck a facility service technician. The light was located at the account. There was a moderate injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681407-2018-00039 |
| MDR Report Key | 7790301 |
| Date Received | 2018-08-16 |
| Date of Report | 2018-07-20 |
| Date of Event | 2018-07-17 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2014-06-26 |
| Date Added to Maude | 2018-08-16 |
| 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 | TRULIGHT DUO |
| Generic Name | SURGICAL LIGHT |
| Product Code | FSQ |
| Date Received | 2018-08-16 |
| Model Number | 1574850 |
| 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 | 2018-08-16 |