MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-26 for 4085 * manufactured by Steris Corporation.
[6051975]
Prior to starting a case the or table was lowered to enable the patient to move onto the table. Before starting the procedure the physician requested the table be heightened. At this time the table would not raise. Staff was unable to adjust the or table to meet the doctor's request. A technician was called into the room to trouble shoot the issue, but the table continued to not function properly. The physician then had to make modifications to continue the procedure. The technician was able to resolve the issue after the conclusion of the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4911620 |
| MDR Report Key | 4911620 |
| Date Received | 2015-06-26 |
| Date of Report | 2015-06-26 |
| Date of Event | 2015-06-10 |
| Report Date | 2015-06-26 |
| Date Reported to FDA | 2015-06-26 |
| Date Reported to Mfgr | 2015-07-14 |
| Date Added to Maude | 2015-07-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | OPERATING TABLE |
| Product Code | FSE |
| Date Received | 2015-06-26 |
| Model Number | 4085 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 5960 HEISLEY ROAD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-26 |