MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-23 for HELIOS 3000 TRACK MOUNTED LIGHT HL3T manufactured by Pelton & Crane.
[32120736]
Upon evaluation by the local pelton & crane distributor it was determined the roll pins were not installed by the distributor during installation. The roll pins will prevent the light from unscrewing from the pole after installation. The pelton & crane installation instructions clearly states to properly install the roll pins during installation of the track light. The installation instructions also lists warnings to ensure the roll pins are installed. Pelton & crane reviewed with the distributor the proper installation process of the roll pins.
Patient Sequence No: 1, Text Type: N, H10
[32120737]
It was reported that a dental professional was positioning a pelton & crane helios track mounted dental light for use when the light assembly fell down from the track assembly glazing the patient on the shin causing a contusion. There were no serious injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2015-00023 |
| MDR Report Key | 5244038 |
| Date Received | 2015-11-23 |
| Date of Report | 2015-10-29 |
| Date of Event | 2015-08-18 |
| Date Mfgr Received | 2015-10-29 |
| Device Manufacturer Date | 2011-12-09 |
| Date Added to Maude | 2015-11-23 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FRANK RAY |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Manufacturer G1 | PELTON & CRANE |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HELIOS 3000 TRACK MOUNTED LIGHT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2015-11-23 |
| Model Number | HL3T |
| Catalog Number | HL3T |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PELTON & CRANE |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-23 |