MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2015-08-21 for OMNI 03337154001 manufactured by Roche Diagnostics.
[25507219]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[25507220]
The customer reported that they perceived a charred smell of the device. The customer switched off the system. No adverse events occurred for this event. The field service engineer changed the power supply of the device. With the new power supply, the device was said to be working fine. The affected power supply was investigated. The first visual inspection showed no sign of burning on the electronic components. A faint smell of burned components could be detected near the power supplier box. The opened power supply showed a lot of dust inside. Upon further investigation of the power supply unit, a defective blown varistor was found within the power supply. There was visual evidence that the part had burned or melted. The input fuse on the ac/dc module was also blown. The varistor is responsible for limiting overvoltage. If the energy is too high, the varistor will be destroyed and often cause a short circuit. The short circuit causes the input fuse of the ac/dc module to blow and caused the burning smell. No specific cause of the varistor failure could be detected. It is assumed that the failure was due to aging of the varistor. The risk of fire is highly unlikely as the surrounding material of the defective varistor is fire retardant material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2015-04005 |
| MDR Report Key | 5022871 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-08-21 |
| Date of Report | 2015-08-21 |
| Date of Event | 2015-05-28 |
| Date Mfgr Received | 2015-06-23 |
| Date Added to Maude | 2015-08-21 |
| 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 | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNI |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2015-08-21 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-21 |