MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-21 for LABPRO COMPUTER N/A B1018-510 manufactured by Beckman Coulter.
[18892930]
It was reported that the labpro aegis computer used with walkaway instruments started smoking and produced a small amount of flames coming from the vent of the computer. A laboratory technician extinguished the flame and smothered the flame. No fire extinguisher was needed. Building facilities removed the computer from the lab. No power surges were observed prior to the event. It was reported that the panels already loaded onto the two walkaway instruments were read manually. There were no reports of injuries or adverse events as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
[19065670]
Labpro computer is not a medical device and is used in conjunction with the walkaway instrument. The computer was returned for evaluation and it was determined, that dust accumulated due to the computer's electronic failure, likely started the smoke and resulted into the flame. The mother board failed and no additional testing could be performed. The manufacturer's field service engineer replaced the damaged computer and installed the required labpro software. The replacement computer was tested with the walkaway instruments and results met the performance specifications. Beckman coulter internal identified for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2015-00060 |
| MDR Report Key | 4789565 |
| Report Source | 05,06 |
| Date Received | 2015-05-21 |
| Date of Report | 2015-04-23 |
| Date of Event | 2015-04-23 |
| Date Mfgr Received | 2015-04-23 |
| Date Added to Maude | 2015-06-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NORMA RAHILL |
| Manufacturer Street | 1584 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163742139 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2040 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95691 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LABPRO COMPUTER |
| Generic Name | INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS |
| Product Code | LRG |
| Date Received | 2015-05-21 |
| Returned To Mfg | 2015-04-29 |
| Model Number | N/A |
| Catalog Number | B1018-510 |
| Lot Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 2040 ENTERPRISE BLVD WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-21 |