MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-27 for WALKAWAY 40 PLUS N/A B1018-283 manufactured by Beckman Coulter.
[23002589]
The minuteman ups was not returned to the manufacturer for evaluation. It was reported that the facility biomedical engineer opened the minuteman ups and observed accumulated lint which is likely the material that ignited. The specification of the temporary and the replacement ups installed by the facility biomedical engineer was not provided to the manufacturer. It was a non microscan ups and not supported by beckman coulter. A microscan minuteman ups specification was provided to the customer. The manufacturer customer technical support explained that ups with less than 2000w would not support the walkaway instrument. At the time of the event, it was reported that the customer was loading 4-panels into the walkaway. The manufacturer customer technical support (cts) recommended connecting the instrument to the emergency line however the customer declined. The customer agreed to the cts recommendation to set up the 4-panels that were currently being loaded, add oil manually and incubate offline in an external incubator at 35? C for 18 hours, dispense the reagents next day and perform manual read. No further action is required. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[23002590]
It was reported that burning smell emanating from the minuteman ups was noted and then it caught fire. The fire immediately extinguished. The operator immediately powered down the computer and the walkaway instrument. There was no damage observed to the instrument. The facility biomedical engineer supplied a temporary ups to be connected only to the labpro computer and not to the walkaway instrument. The biomedical engineer opened the ups and observed accumulated lint. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919016-2015-00098 |
| MDR Report Key | 4943124 |
| Date Received | 2015-07-27 |
| Date of Report | 2015-06-28 |
| Date of Event | 2015-06-28 |
| Date Mfgr Received | 2015-06-28 |
| Device Manufacturer Date | 2013-01-22 |
| Date Added to Maude | 2015-07-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 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 | 0 |
| Brand Name | WALKAWAY 40 PLUS |
| Generic Name | INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS |
| Product Code | LRG |
| Date Received | 2015-07-27 |
| Model Number | N/A |
| Catalog Number | B1018-283 |
| Lot Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-07-27 |