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 2015-08-18 for OMNI 03337154001 manufactured by Roche Diagnostics.
[23951627]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[23951648]
The customer complained of a burnt smell from the cobas b 221 instrument. The customer turned the system off. The field service engineer changed the power supply cord. Afterwards, the instrument worked fine. No adverse event occurred. No patients were affected. The power supply unit with serial number (b)(4) that was connected to the b 221 instrument with serial number 7116 was returned for investigation. During further investigation of the power supply unit a blown ac/dc input fuse was identified. Evidence was provided that shows visible signs of melting and burning in the power supply unit. The cause was determined to be a defective varistor. The varistor is responsible to limit overvoltage. If the energy level is too high the varistor can become damaged and cause a short circuit causing a burning smell. The risk of fire is highly unlikely. The surrounding material is fire-retardant. No specific cause for the defective varistor could be identified. A possible root cause of the issue may be a temporary failure due to the age of the power supply attached to the instrument.
Patient Sequence No: 1, Text Type: D, B5
[28346516]
Clarification was received that date received by manufacturer should be 06/23/2015. Roche diagnostics acknowledges the update to 06/23/2014 now renders the submission of the initial medical device report outside of the required 30 day timeframe as defined in 21 cfr 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03988 |
| MDR Report Key | 5011495 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-08-18 |
| Date of Report | 2015-08-21 |
| Date of Event | 2015-06-07 |
| Date Mfgr Received | 2015-08-11 |
| Date Added to Maude | 2015-08-18 |
| 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 | 2015-08-18 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| 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 | 2015-08-18 |