MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-04-13 for OMNI S ANALYZER 03337138001 manufactured by Roche Diagnostics.
[5643486]
The customer complained of a burning smell from the instrument. The instrument was showing multiple error messages. The customer turned the instrument off and unplugged it. The field service engineer reported electronic board components were burnt and smoke was produced. No adverse event occurred. The customer was sent a loaner instrument.
Patient Sequence No: 1, Text Type: D, B5
[13132559]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[21686544]
The ts-pc unit with serial number (b)(4) was sent in for investigation. The investigation found that the input capacitor on one of the dc-dc converters was damaged leaving behind traces of melted material and a persistent burning smell. A specific root cause could not be identified. A possible root cause could be related to a slight manufacturing defect in connection with voltage spikes across the capacitor. The more likely root cause is a component failure. The risk of fire is highly unlikely. The surrounding material (display unit) is made of fire-retardant material.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-02964 |
| MDR Report Key | 4685149 |
| Report Source | 01,05,06 |
| Date Received | 2015-04-13 |
| Date of Report | 2015-05-14 |
| Date of Event | 2015-03-23 |
| Date Mfgr Received | 2015-03-23 |
| Date Added to Maude | 2015-04-13 |
| 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 | 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 S ANALYZER |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2015-04-13 |
| Model Number | NA |
| Catalog Number | 03337138001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2015-04-13 |