MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-26 for HELIOS 3000 CEILING MOUNTED DENTAL LIGHT HL3C manufactured by Pelton & Crane.
[81260558]
Upon evaluation by the distributor, it was determined the set screws were not properly secured by the distributor during installation. The set screws will prevent the light from unscrewing from the ceiling mount arm after installation. The pelton & crane installation instructions clearly states to secure all set screws during installation of the ceiling light. The installation instructions also lists warnings to ensure the set screws are properly tightened. The distributor service technician reattached the light and secured the sets screws.
Patient Sequence No: 1, Text Type: N, H10
[81260559]
It was reported that a dr. Was positioning a pelton & crane dental light for use when the light fell down and onto the patients stomach. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2017-00043 |
| MDR Report Key | 6743932 |
| Date Received | 2017-07-26 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-06-29 |
| Date Mfgr Received | 2017-06-30 |
| Device Manufacturer Date | 2011-08-24 |
| Date Added to Maude | 2017-07-26 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 CEILING MOUNTED DENTAL LIGHT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2017-07-26 |
| Model Number | HL3C |
| Catalog Number | HL3C |
| 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 | 2017-07-26 |