MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-04 for COULTER LH 750 SLIDEMAKER ANALYZER 6605633 manufactured by Beckman Coulter, Inc..
[1718190]
A customer contacted beckman coulter inc. (bci) stating that there was a bloody leak coming from the coulter lh 750 slidemaker analyzer. There was no exposure to mucous membranes or open lesions, and operator did not seek medical attention. There was no death, injury, or affect to user. The operator did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
[9096502]
A field service engineer (fse) was dispatched on (b)(4) 2011 and found that the probe wash drain tubing had come off of the fitting on the feed through bulk head. The fse replaced the tubing and reseated the tubing to the fitting. The fse verified performance and no leak was observed.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1061932-2011-00117 |
MDR Report Key | 2007381 |
Report Source | 06 |
Date Received | 2011-03-04 |
Date of Report | 2011-02-03 |
Date of Event | 2011-02-03 |
Date Mfgr Received | 2011-02-03 |
Device Manufacturer Date | 2007-10-01 |
Date Added to Maude | 2012-02-08 |
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 | 11800 SW 147TH AVENUE |
Manufacturer City | MIAMI FL 33196 |
Manufacturer Country | US |
Manufacturer Postal Code | 33196 |
Single Use | 3 |
Remedial Action | RP |
Previous Use Code | 3 |
Removal Correction Number | N/A |
Event Type | 3 |
Type of Report | 3 |
Brand Name | COULTER LH 750 SLIDEMAKER ANALYZER |
Generic Name | AUTOMATED DIFFERENTIAL CELL COUNTER |
Product Code | LOQ |
Date Received | 2011-03-04 |
Model Number | LH 750 |
Catalog Number | 6605633 |
Lot Number | N/A |
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 | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2011-03-04 |