MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-01-22 for EUREKA COLLIMATOR LINEAR II 70-20380-6 manufactured by Midmark Corporation.
[1418581]
A dealer service engineer called progeny on (b) (6) 2009 regarding a collimator, (b) (4), whose lamp circuit failed in the "on" condition causing the cover to begin to melt. The customer alleged that the collimator internal wiring insulation caught fire and continued to burn until the wiring connection failed which stopped the electric current and burning ceased. No injuries were reported. The unit was repaired by progeny technician on 12/28/2009.
Patient Sequence No: 1, Text Type: D, B5
[8348422]
An investigation of the unit revealed that the triac had failed. The ceramic insulator, which is used to remove the heat from the triac and electrically isolate the unit from ground, was broken, isolating the triac from the chassis. This caused the triac to overheat and fail in a shorted mode. The triac was replaced and the unit operated normally. In addition, a collimator (b) (4) was tested to simulate the failure mode. The customer complaint alleging "fire" associated with a shorted out lamp circuit could not be duplicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423380-2009-00031 |
| MDR Report Key | 1593429 |
| Report Source | 08 |
| Date Received | 2010-01-22 |
| Date of Report | 2010-01-22 |
| Date of Event | 2009-12-29 |
| Date Mfgr Received | 2009-12-29 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2010-05-25 |
| 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 | LISA BARTAKOVICS |
| Manufacturer Street | 675 HEATHROW DR |
| Manufacturer City | LINCOLNSHIRE IL 60089 |
| Manufacturer Country | US |
| Manufacturer Postal | 60089 |
| Manufacturer Phone | 8474159800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EUREKA COLLIMATOR |
| Product Code | IZW |
| Date Received | 2010-01-22 |
| Returned To Mfg | 2010-01-13 |
| Model Number | LINEAR II |
| Catalog Number | 70-20380-6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORPORATION |
| Manufacturer Address | 675 HEATHROW DR. LINCOLNSHIRE IL 60089 US 60089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-22 |