MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-18 for HELIOS 3000 manufactured by Kavo (former Pelton And Crane).
[106029788]
Helios 3000 dental ceiling track mounted operating light manufactured by kavo dental technologies got separated from mounting pall falling and striking the doctor on the head. The equipment is very heavy it caused severe head and neck injury that required 2 surgeries and caused permanent damage. There are at least over 12 cases reported to fda since 2008 by the same company with identical problem. I have been trying to make kavo to do something about it to prevent more injuries. I reported this event to fda with no response... The last event happened (b)(6) 2018. This is very disturbing and should be dealt with before this equipment kills the child.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076555 |
| MDR Report Key | 7442636 |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-17 |
| Date of Event | 2012-10-25 |
| Date Added to Maude | 2018-04-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HELIOS 3000 |
| Generic Name | DENTAL OPERATING LIGHT |
| Product Code | EAZ |
| Date Received | 2018-04-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAVO (FORMER PELTON AND CRANE) |
| Manufacturer Address | CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2018-04-18 |