MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-06-17 for FP 1000 CELL PREPARATION SYSTEM N/A 624922 manufactured by Beckman Coulter, Inc..
[2728642]
On (b)(6) 2012, customer reported arcing coming from the on/off button of the fp1000 instrument. This occurred when the on-switch was activated. There was no report of death or injury and medical attention was not sought. There was no report that the fire department was notified. The use of a fire extinguisher was not required. No erroneous patient results were generated during this event. Field service engineer (fse) inspected the instrument and replaced the on/off switch. After removing the faulty switch the fse disassembled it and found that the connector was burnt from the arcing. This resolved the issue and no further problems have been reported.
Patient Sequence No: 1, Text Type: D, B5
[9926876]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-01981 |
| MDR Report Key | 2618773 |
| Report Source | 01,05,06 |
| Date Received | 2012-06-17 |
| Date of Report | 2012-05-22 |
| Date of Event | 2012-05-22 |
| Date Mfgr Received | 2012-05-22 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2012-10-11 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 SOUTH KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FP 1000 CELL PREPARATION SYSTEM |
| Generic Name | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2012-06-17 |
| Model Number | N/A |
| Catalog Number | 624922 |
| ID Number | SOFTWARE VERSION 1.5 |
| 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 | 2012-06-17 |