MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-28 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter Inc..
[2133976]
A customer contacted beckman coulter inc. (bec) reporting that the immage 800 immunochemistry system was making a groaning sound and fluid was dripping from the wash station tower and the sample probe. No injury was reported and no erroneous results were generated.
Patient Sequence No: 1, Text Type: D, B5
[9273768]
Bec cts (customer technical support) directed the customer to "cold boot" the system. When cts called back after the customer had performed the reboot, the customer stated the instrument was still leaking. Cts generated a service request. A field service engineer (fse) went on-site and replaced the vacuum pump diaphragm, pump check valve in pump exhaust line and removed a clog from the sample drain. The customer ran controls and repair was verified per established procedures. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-03324 |
| MDR Report Key | 2183449 |
| Report Source | 06 |
| Date Received | 2011-07-28 |
| Date of Report | 2011-06-29 |
| Date of Event | 2011-06-29 |
| Date Mfgr Received | 2011-06-29 |
| Device Manufacturer Date | 2008-03-14 |
| Date Added to Maude | 2012-04-18 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7168282419 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JQX |
| Date Received | 2011-07-28 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| 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 | 2011-07-28 |