MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-05-02 for OUTPATIENT II DOUBLE CEILING 0224132 NA manufactured by Burton Medical Products.
[445039]
During surgery, acent of something burning became increasingly stronger. Physician noticed one side of the light had caught fire. Nurse switched off the light using the wall dimmer. As soon as light was turned off the fire dissipated. No injuries occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2018492-2006-00007 |
| MDR Report Key | 708673 |
| Report Source | 06 |
| Date Received | 2006-05-02 |
| Date of Report | 2006-04-26 |
| Date of Event | 2006-03-13 |
| Date Mfgr Received | 2006-03-13 |
| Date Added to Maude | 2006-05-09 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHELSEA MITCHELL |
| Manufacturer Street | 21100 LASSEN AVE |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8187018700 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OUTPATIENT II DOUBLE CEILING |
| Generic Name | EXAMINATION LIGHT |
| Product Code | KYT |
| Date Received | 2006-05-02 |
| Model Number | 0224132 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 697721 |
| Manufacturer | BURTON MEDICAL PRODUCTS |
| Manufacturer Address | * CHATSWORTH CA * US |
| Baseline Brand Name | DOUBLE CEILING MOUNT |
| Baseline Generic Name | CEILING MOUNT |
| Baseline Model No | 0224132 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | MINOR SURGERY LIGHTS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K851742 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-02 |