MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-30 for SYNCHRON CX3 DELTA 467501 manufactured by Beckman Coulter, Inc..
[2258183]
On (b)(6) 2011, customer reported that the (b)(4) instrument analog board 1 started to smoke and the l1 inductor component melted two hours after a field service engineer (fse) replaced the analog board 1. Fse was on site when the issue occurred and replaced the analog board and the issue was resolved. No injuries or erroneous patient results were reported.
Patient Sequence No: 1, Text Type: D, B5
[9477253]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-05900 |
| MDR Report Key | 2270981 |
| Report Source | 05,06 |
| Date Received | 2011-09-30 |
| Date of Report | 2011-08-30 |
| Date of Event | 2011-08-30 |
| Date Mfgr Received | 2011-08-30 |
| Device Manufacturer Date | 1995-05-04 |
| Date Added to Maude | 2012-02-29 |
| 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 | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 SOUTH KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 SOUTH KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX3 DELTA |
| Generic Name | ANALYZER, CHEMISTRY, MICRO |
| Product Code | JJF |
| Date Received | 2011-09-30 |
| Model Number | CX3 DELTA |
| Catalog Number | 467501 |
| 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 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-30 |