MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-21 for HELIOS 3000 WALL MOUNTED LIGHT HL3WL manufactured by Pelton & Crane.
[51055922]
Upon visual inspection by the local pelton & crane distributor, it was determined that the locking key and set screw were not properly secured on the light arm. The function of the locking key and set screw is to secure the light arm assembly together. The device was not returned to pelton & crane but rather it was serviced and placed back into use at the doctor's office and has been tested and is now functioning properly. A review of pelton & crane's helios 3000 dental light installation manual clearly documents and illustrates how to properly install the locking key and set screw during installation of the dental light. Pelton & crane reviewed the installation issue with the distributor.
Patient Sequence No: 1, Text Type: N, H10
[51055923]
A medical professional was positioning a helios hl3wl for use when the light arm came apart and fell down towards the ground. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2016-00019 |
| MDR Report Key | 5814055 |
| Date Received | 2016-07-21 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-06-22 |
| Device Manufacturer Date | 2012-03-13 |
| Date Added to Maude | 2016-07-21 |
| 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 WALL MOUNTED LIGHT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2016-07-21 |
| Model Number | HL3WL |
| Catalog Number | HL3WL |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-07-21 |