MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-17 for HELIOS 3000 TRACK MOUNTED LIGHT HL3T manufactured by Pelton & Crane.
[40853977]
Upon evaluation by the dr. 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 trolly 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. Pelton & crane recommended to the dr. To call his local distributor to re-install the light to the trolley but the dr. Declined to do so.
Patient Sequence No: 1, Text Type: N, H10
[40853978]
It was reported from a doctors office that a pelton & crane helios track mounted dental light had unthreaded from the trolley and fell to the floor. There was no patient involved and no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2016-00006 |
| MDR Report Key | 5507154 |
| Date Received | 2016-03-17 |
| Date of Report | 2016-02-22 |
| Date of Event | 2016-02-22 |
| Date Mfgr Received | 2016-02-22 |
| Device Manufacturer Date | 2010-02-17 |
| Date Added to Maude | 2016-03-17 |
| 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 | DENTIST |
| 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 | 2016-03-17 |
| Model Number | HL3T |
| Catalog Number | HL3T |
| 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 | 2016-03-17 |