MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-08 for 3080 SP SURGICAL TABLE manufactured by Steris Corporation - Montgomery.
[110913602]
No report of procedure delay or cancellation. The surgical table is approximately 23 years old and is not under steris service agreement for maintenance activities. The facility's biomed department is responsible for all maintenance activities. The 3080sp operator manual states (pg. 6-1), "warning - personal injury and/or equipment damage hazard: safe and reliable operation of this equipment requires regularly scheduled preventive maintenance, in addition to the regular routine maintenance. Contact steris to schedule. " a steris service technician arrived onsite to inspect the surgical table. The technician tested the table's function and articulations and was unable to duplicate the reported event. Based on the description of the reported event by the user facility it appears a downward drift occurred. If the table does experience a drift the correct method is to re-energize the hydraulic system by turning on the hand control and repeating the desired movement/articulation. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[110913603]
The user facility reported that during a patient procedure the 3080sp surgical table lowered in height without being commanded to do so. User facility personnel utilized the table's auxiliary override controls and placed the table into the desired position. The procedure was completed successfully, and no injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2018-00044 |
| MDR Report Key | 7584016 |
| Date Received | 2018-06-08 |
| Date of Report | 2018-06-08 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-05-09 |
| Date Added to Maude | 2018-06-08 |
| 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 | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 3080 SP SURGICAL TABLE |
| Generic Name | SURGICAL TABLE |
| Product Code | FWW |
| Date Received | 2018-06-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-08 |