MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-09-01 for IMMAGE IMMUNOCHEMISTRY SYSTEM 470000 manufactured by Beckman Coulter Inc..
[2324809]
A customer contacted beckman coulter inc (bec) to report a reaction wheel temperature error after a preventive maintenance. The customer noted burning smell when cuvette cover was lifted. The customer shut down the instrument. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[9458761]
A bec field service engineer (fse) replaced a defective circulation fan in the reaction wheel chamber, which was the cause of the event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-04696 |
| MDR Report Key | 2231995 |
| Report Source | 06 |
| Date Received | 2011-09-01 |
| Date of Report | 2011-02-21 |
| Date of Event | 2011-02-21 |
| Date Mfgr Received | 2011-02-21 |
| Device Manufacturer Date | 2001-06-28 |
| Date Added to Maude | 2012-05-21 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2011-09-01 |
| Model Number | IMMAGE |
| Catalog Number | 470000 |
| Lot Number | N/A |
| ID Number | SW 1.6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-01 |