MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-25 for BENCHMARK ULTRA STAINER MODULE 05342716001 manufactured by Ventana Medical Systems.
[165643668]
During the visit from the local field service engineer, it was indicated that the air filter tubing going to the waste manifold fitting broke, causing fluid to pour onto the power plug causing to short. The customer site did not want the instrument replaced; as such, parts were removed and exchanged. After the replacement of parts, the local field service engineer performed an operational qualification run on the instrument. The instrument is now performing within acceptable operating specifications. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[165643669]
A us customer stated that there was smoke coming from the benchmark ultra stainer module, and there was no alarm or error generated. The customer indicated that the instrument automatically shut off. The operator left the lab temporarily because of the quantity of smoke. There was no harm or injury indicated, and lab operator did not seek any medical attention. A local field service engineer was dispatched to the customer site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2019-00019 |
| MDR Report Key | 9120312 |
| Date Received | 2019-09-25 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-08-30 |
| Date Mfgr Received | 2019-08-30 |
| Date Added to Maude | 2019-09-25 |
| 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 | 2019-09-25 |
| 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 |
| Manufacturer Address | 1910 E. INNOVATION PARK DR. NA TUCSON AZ 85755 US 85755 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-25 |