MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-06 for HELIOS HL3T 0.848.5200 manufactured by Pelton & Crane.
[64441140]
Upon evaluation by the distributor, it was determined the roll pins and set screws were not installed by the distributor during installation. The roll pins and set screws will prevent the light from unscrewing from the trolley after installation. The pelton & crane installation instructions clearly states to properly install the roll pins and set screws during installation of the track light. The installation instructions also lists warnings to ensure the roll pins and set screws are installed. The distributor service technician ordered the roll pins and set screws and will properly install the light.
Patient Sequence No: 1, Text Type: N, H10
[64441141]
The doctor was talking with the patient when the dental light fell down onto the patients legs. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2017-00001 |
| MDR Report Key | 6229395 |
| Date Received | 2017-01-06 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-12-08 |
| Date Mfgr Received | 2016-09-12 |
| Device Manufacturer Date | 2014-11-20 |
| Date Added to Maude | 2017-01-06 |
| 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. 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 |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2017-01-06 |
| Model Number | HL3T |
| Catalog Number | 0.848.5200 |
| Operator | DENTIST |
| 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 | 2017-01-06 |