MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-07 for ZEON APOLLO ZZ-APOLLO-TTL manufactured by Kerr Corporation.
[4321202]
A complainant alleged that the zeon apollo device got hot, slightly burning the desk, and the light bezzle came off.
Patient Sequence No: 1, Text Type: D, B5
[11689001]
No injuries were associated with this incident; the complainant is doing fine. To date, the product has not been returned; therefore, no evaluation can be conducted. This incident is mdr reportable as a malfunction because the device could cause or contribute to a serious injury if the malfunction were to recur.
Patient Sequence No: 1, Text Type: N, H10
[31117666]
The unit was returned and a visual and physical inspection revealed that there were no damages to the battery pack and the charger. Contrary to the alleged complaint, both items were working properly. It was revealed that the headlight was exposed to an excessive amount of heat causing the headlight to melt. After reproducing the failure with the apollo components, it is concluded that the apollo battery pack is not capable of producing a sufficient amount of current that caused the plastic lens in the headlight to melt. A power source capable of producing about five (5) times more power than the apollo pack is required in order to melt the plastic lens of the headlight.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003848022-2014-00002 |
| MDR Report Key | 3667409 |
| Report Source | 05 |
| Date Received | 2014-03-07 |
| Date of Report | 2014-02-11 |
| Date of Event | 2014-02-11 |
| Date Mfgr Received | 2014-02-11 |
| Date Added to Maude | 2014-05-14 |
| 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 | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W. COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | KERR CORPORATION |
| Manufacturer Street | 3225 DEMING WAY SUITE 190 |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53562 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZEON APOLLO |
| Generic Name | SURGICAL HEADLIGHT |
| Product Code | EBA |
| Date Received | 2014-03-07 |
| Catalog Number | ZZ-APOLLO-TTL |
| Operator | DENTAL ASSISTANT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 3225 DEMING WAY SUITE 190 MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-07 |