MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-23 for HELIOS 3000 CABINET MOUNTED LIGHT HL3CB manufactured by Pelton And Crane.
[5289183]
A dental professional was pushing a pelton and crane helios 3000 light away from use when the light arm assembly came apart and fell down towards the ground. The light head hit the pt on their knee. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[12653284]
Upon visual inspection by the local pelton and crane distributor, it was determined that the locking key and locking key screw were not installed on the helios 3000 dental light arm. The function of the locking key and locking key screw is to secure the light arm assembly together. The device was not returned to pelton and crane but rather it was serviced and placed back in use at the doctor's office and has been tested and is now functioning to manufacturer's specifications. A review of pelton and crane's helios 3000 dental light installation manual clearly documents and illustrates how to properly install the locking key and locking key screw during installation of the dental light. Pelton and crane reviewed the installation issue with the distributor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2014-00017 |
| MDR Report Key | 4377406 |
| Report Source | 05,06 |
| Date Received | 2014-12-23 |
| Date of Report | 2014-12-09 |
| Date of Event | 2014-12-08 |
| Date Mfgr Received | 2014-12-09 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2015-01-13 |
| 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 | 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 3000 CABINET MOUNTED LIGHT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2014-12-23 |
| Model Number | HL3CB |
| Catalog Number | HL3CB |
| 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 AND CRANE |
| Manufacturer Address | 11727 FRUEHAUF DR. CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-23 |