MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-05 for IMMAGE? IMMUNOCHEMISTRY SYSTEM 470000 manufactured by Beckman Coulter Inc..
[2071484]
A customer contacted beckman coulter inc. (bci) reporting a fluid leak in the immage immunochemistry system. The sample and reagent probe wash stations were overflowing. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[9286840]
A field service engineer (fse) went on-site (b)(4) 2011 and narrowed the problem down to the vacuum pump after communicating with the customer. Fse rebuilt the vacuum pump and replaced 2 check valves and 2 filters. The vacuum system was functioning properly following repairs. Fse also replaced the sample and reagent probes. Instrument alignments were reworked and calibrations were performed. Repairs were verified per established procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02836 |
| MDR Report Key | 2150007 |
| Report Source | 06 |
| Date Received | 2011-07-05 |
| Date of Report | 2011-06-06 |
| Date of Event | 2011-06-06 |
| Date Mfgr Received | 2011-06-06 |
| Device Manufacturer Date | 2000-08-17 |
| Date Added to Maude | 2012-03-15 |
| 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 BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? IMMUNOCHEMISTRY SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JQX |
| Date Received | 2011-07-05 |
| Model Number | NA |
| Catalog Number | 470000 |
| Lot Number | NA |
| 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 BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-05 |