MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-10-14 for ICHEM? VELOCITY? AUTOMATED URINE CHEMISTRY SYSTEM 2.5 ICHEM VELOCITY INSTRUMENT COMPUTERLESS BRING U 700-7177-001 manufactured by Beckman Coulter.
[162243100]
The fse replaced the pc6 and conducted unrelated preventive maintenance, the system was left fully operational. The fse was contacted and confirmed that the computer was not opened by them to assess the extent of the damage. The fse is arranging the return of the pc6 to beckman coulter for evaluation. Investigation is ongoing. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[162243101]
The customer reported that was a fire in the computer tower for their iricell system. The iricell is composed of an ichem? Velocity? Automated urine chemistry system and an iq 200 urine analyzer. On 16-sep-2019, the customer called customer technical support (cts) to report that their iricell system pc6 computer caught fire and the fire department was called. The pc6 is used for both the ichem velocity and iq200 instruments. The customer confirmed that there was no injury to any laboratory personnel and that the lab did not suffer any damage as a result of the alleged fire. The customer stated to the field service engineer (fse) that the pc6 had caught fire internally and that it was blowing sparks/fire out of the fans and vents and that there was no damage observed as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2019-01122 |
| MDR Report Key | 9188461 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-10-14 |
| Date of Report | 2019-10-14 |
| Date of Event | 2019-09-16 |
| Date Mfgr Received | 2019-09-16 |
| Date Added to Maude | 2019-10-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LAURIE O'RIORDAN |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal | 331962031 |
| Manufacturer Phone | 3053802874 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DR. |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICHEM? VELOCITY? AUTOMATED URINE CHEMISTRY SYSTEM |
| Generic Name | AUTOMATED URINALYSIS SYSTEM |
| Product Code | KQO |
| Date Received | 2019-10-14 |
| Model Number | 2.5 ICHEM VELOCITY INSTRUMENT COMPUTERLESS BRING U |
| Catalog Number | 700-7177-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | LISMEEHAN O'CALLAGHAN'S MILLS/CO CLARE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-14 |