MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-02-03 for HELIOS TRACK LIGHT AND FLEXIBLE MONITOR MOUNT HT3TM HL3TM manufactured by Pelton & Crane.
[21325893]
It was reported that a pelton and crane helios dental light had fallen down towards the ground. There were no witnesses to this event as no one was in the room when the event took place. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[21595367]
Upon evaluation by the local pelton and crane distributor it was determined the set screws were loose and roll pins were not installed by the distributor during installation. The set screws and roll pins will prevent the light from unscrewing from the pole after installation. The pelton and crane installation instructions clearly states to properly install the set screws and roll pins during installation of the track light. The installation instructions also list warnings to insure the set screws and roll pins are properly installed. Pelton and crane reviewed with the distributor the proper installation processes of the set screws and roll pins.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2015-00001 |
| MDR Report Key | 4488386 |
| Report Source | 08 |
| Date Received | 2015-02-03 |
| Date of Report | 2015-01-09 |
| Date of Event | 2015-01-07 |
| Date Mfgr Received | 2015-01-09 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2015-03-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | FRANK RAY |
| Manufacturer Street | 11727 FRUEHAUF DR. |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HELIOS TRACK LIGHT AND FLEXIBLE MONITOR MOUNT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2015-02-03 |
| Model Number | HT3TM |
| Catalog Number | HL3TM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PELTON & CRANE |
| Manufacturer Address | 11727 FRUEHAUF DR. CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-03 |