MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-10-07 for LIGHT FANTASTIC II TRACK MOUNTED DENTAL LIGHT LFTII manufactured by Pelton & Crane.
[4910565]
It was reported that a pelton & crane dental light had come apart at the arm assembly and fell down towards the ground. No one was in the room when the event took place.
Patient Sequence No: 1, Text Type: D, B5
[12359528]
The (b)(4) distributor inspected the dental light at the doctors office and was told by the dental office, the light arm rotational stop mechanism had seized together around a year ago; however, the facility continued to use the dental light without having it repaired. The function of the rotational stop is to prevent the light from rotating more than 350 degrees. As a result, the light arm assembly had rotated numerous times past 360 degrees during use allowing the light arm assembly to unscrew from the light post assembly and fall. The (b)(4)distributor repaired the light and placed it back into service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2014-00014 |
| MDR Report Key | 4156551 |
| Report Source | 08 |
| Date Received | 2014-10-07 |
| Date of Report | 2014-09-09 |
| Date of Event | 2014-09-04 |
| Date Mfgr Received | 2014-09-09 |
| Device Manufacturer Date | 2002-01-01 |
| Date Added to Maude | 2014-10-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | FRANK RAY, MGR |
| 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 | LIGHT FANTASTIC II TRACK MOUNTED DENTAL LIGHT |
| Generic Name | DENTAL OPERATING LIGHT |
| Product Code | EAZ |
| Date Received | 2014-10-07 |
| Model Number | LFTII |
| Catalog Number | LFTII |
| 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 & CRANE |
| Manufacturer Address | 11727 FRUEHAUF DR. CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-07 |