MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-06-25 for CIRRUS HD OCT 4000 0496-090 manufactured by Carl Zeiss Meditec, Inc..
[17446845]
A health care professional reported that between pt examinations with the cirrus hd-oct 4000, he observed that the instrument was emitting white smoke and the display screen was blank. He immediately unplugged the power cable and covered the instrument with a fire blanket. He subsequently removed the fire blanket and found that one of the instrument covers had been deformed and flames were visible. He used a foam fire extinguisher to put out the fire. It was reported that there were no injuries and the fire was confined to the instrument.
Patient Sequence No: 1, Text Type: D, B5
[17775593]
The device, which was returned to the manufacturer, underwent an analysis of possible failure modes at a third-party lab. The lab determined that a tantalum capacitor failed and discharged a small extreme temperature particle that lodged in the insulation of a cable. The insulation of the cable acted as fuel for the resulting fire. (b)(4). Site contact: same as initial reporter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2918630-2013-00001 |
| MDR Report Key | 3193180 |
| Report Source | 01,05 |
| Date Received | 2013-06-25 |
| Date of Report | 2013-06-25 |
| Date of Event | 2013-05-28 |
| Date Mfgr Received | 2013-05-28 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2013-09-19 |
| 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 | JUDY BRIMACOMBE |
| Manufacturer Street | 5160 HACIENDA DR. |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574616 |
| Manufacturer G1 | CARL ZEISS MEDITEC, INC. |
| Manufacturer Street | 5160 HACIENDA DR. |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94568 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIRRUS HD OCT |
| Generic Name | OPHTHALMOSCOPE, AC-POWERED |
| Product Code | HLI |
| Date Received | 2013-06-25 |
| Model Number | 4000 |
| Catalog Number | 0496-090 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC, INC. |
| Manufacturer Address | 5160 HACIENDA DRIVE DUBLIN CA 94568 US 94568 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-25 |