MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-01 for 750-700 05265231001 manufactured by Ventana Medical Systems, Inc.
[47503365]
The heater pads within the slide tray may be slightly loose which could cause drips on the floor. Fse tightened all the heater pads to prevent any drips.
Patient Sequence No: 1, Text Type: N, H10
[47503366]
Lab staff fell due to liquid allegedly coming from underneath the instrument. Staff did not have to seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2016-00003 |
| MDR Report Key | 5693571 |
| Date Received | 2016-06-01 |
| Date of Report | 2016-06-01 |
| Date of Event | 2016-05-03 |
| Date Mfgr Received | 2016-05-04 |
| Date Added to Maude | 2016-06-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA TIM GIBLIN |
| Manufacturer Street | 1910 EAST INNOVATION PARK DR NA |
| Manufacturer City | TUSCON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777035 |
| Manufacturer G1 | VENTANA MEDICAL SYSTEMS, INC |
| Manufacturer Street | 1910 E INNOVATION PARK DR NONE |
| Manufacturer City | TUCSON AZ 857551962 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 857551962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | BENCHMARK XT |
| Product Code | MYA |
| Date Received | 2016-06-01 |
| Model Number | 750-700 |
| Catalog Number | 05265231001 |
| Lot Number | NA |
| ID Number | UDI# 04015630981069 |
| Operator | OTHER HEALTH CARE 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 1910 E INNOVATION PARK DR TUCSON AZ 857551962 US 857551962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-01 |