MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-07 for HELIOS 1800 TRACK MOUNTED LIGHT HLT manufactured by Kavo Dental Technologies, Llc.
[116388401]
Upon evaluation by the distributor, it was determined the roll pins were not installed by the distributor during installation and the set screws were loose and not properly secured. The roll pins and set screws will prevent the light from unscrewing from the trolley 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 & crance shipped roll pins and set screws directly to the doctors office who has been instructed to have his authorized pelton & crane dealer install them on his helios dental light.
Patient Sequence No: 1, Text Type: N, H10
[116388402]
A dental assistant was positioning away from use a helios track mounted dental light when the light fell from the trolly towards the floor. The dental assistant pushed the light away from the patient when it fell. The patient told the dental assistant the light did not hit them but later told the dr. The light did hit them on the head and caused a small bump. There were no serious injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2018-00022 |
| MDR Report Key | 7758225 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-07-11 |
| Date Mfgr Received | 2018-07-12 |
| Device Manufacturer Date | 2014-07-28 |
| Date Added to Maude | 2018-08-07 |
| 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 | KAVO DENTAL TECHNOLOGIES, LLC |
| 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 | 3 |
| Brand Name | HELIOS 1800 TRACK MOUNTED LIGHT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2018-08-07 |
| Model Number | HLT |
| Catalog Number | HLT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAVO DENTAL TECHNOLOGIES, LLC |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-07 |