MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-07 for BENCHMARK ULTRA STAINER MODULE 05342716001 manufactured by Ventana Medical Systems Inc.
[153837681]
After the incident, the local field service engineer (fse) checked the waste filter for leaks and found none, and there was no residual fluid in the instrument power plug either. When the fse placed the transformer on its side, it dampened the cloth it was sitting on, suggesting an instrument leak could have been a contributing factor to the reported fire. Investigation is ongoing. The affected parts and instrument are being requested to be returned for investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[153837682]
While at a us customer site, a local field service engineer reported smoke and flames coming from the benchmark ultra stainer module's power plug. The local fse was performing an operational qualification run when the instrument experienced an electrical short that damaged the instrument power plug, the emi filter, and transformer. The instrument had been powered for 40 minutes and was in the middle of ramping up heaters for a cleaning cycle. It was indicated to be an intense short, enough to create ash in the air and smoke. The customer site's circuit breaker tripped shortly afterward and stopped the power to the instrument. No fire extinguisher was used to smother the fire. The fse indicated this was a high arc event and was immediately dispersed when power was cut off by the breaker tripping. There situation did not lead to any laboratory evacuations and no one was harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2019-00013 |
| MDR Report Key | 8871129 |
| Date Received | 2019-08-07 |
| Date of Report | 2019-08-07 |
| Date of Event | 2019-07-09 |
| Date Mfgr Received | 2019-07-09 |
| Date Added to Maude | 2019-08-07 |
| 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 | NA STACIE-ANN CREIGHTON |
| Manufacturer Street | 1910 E INNOVATION PARK DR NA |
| Manufacturer City | TUSCON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BENCHMARK ULTRA STAINER MODULE |
| Generic Name | SLIDE STAINER, AUTOMATED |
| Product Code | KPA |
| Date Received | 2019-08-07 |
| Model Number | NA |
| Catalog Number | 05342716001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS INC |
| Manufacturer Address | 1910 E INNOVATION PARK DR NA TUCSON AZ 85755 US 85755 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-07 |