MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-30 for HELIOS 3000 TRACK MOUNTED DENTAL LIGHT HL3T manufactured by Pelton & Crane.
[91357158]
The device was not returned to pelton & crane but rather visually evaluated by a pelton & crane authorized distributor. The distributor informed pelton & crane the ceiling support/bracing was not adequate to support a dental track light as required by pelton & cranes installation instructions. Therefore this is considered installation error. Pelton & cranes installation instructions and warnings clearly identify the need to provide adequate framing to support at least 200 pounds in regards to proper ceiling bracing requirements to support the pelton & crane helios track mounted dental lights. Please note, the dealer nor the doctor could provide the serial number of the pelton & crane helios track mounted dental light therefore pelton & crane is unable to determine the serial number or the age of the device. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[91357159]
The dr. Was positioning a pelton & crane helios light when the complete light with track fell off the ceiling hitting the patient on the arm causing a small scratch and contusion to their bicep. No medical treatment was required. No serious injuries reported. This mdr is linked to manufacturer report 1017522-2017-00061.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2017-00060 |
| MDR Report Key | 6989083 |
| Date Received | 2017-10-30 |
| Date of Report | 2017-10-03 |
| Date of Event | 2017-09-26 |
| Date Mfgr Received | 2017-10-03 |
| Date Added to Maude | 2017-10-30 |
| 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 | SERVICE PERSONNEL |
| 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 TRACK MOUNTED DENTAL LIGHT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2017-10-30 |
| Model Number | HL3T |
| Catalog Number | HL3T |
| 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 | 2017-10-30 |