MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-15 for 3080SP SURGICAL TABLE manufactured by Steris Corporation - Montgomery.
[117446924]
The surgical table was installed at the customer's location in 1995 and has been in use for approximately 23 years. It is not under steris service agreement. The user facility's biomed department is responsible for all maintenance activities. A review of service records indicates steris has not been contacted to perform any service activities on this unit since march 2006. The 3080sp surgical table 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 preventive maintenance. A steris service technician arrived onsite to inspect the table and identified that the bolts which secure the tilt cylinder bracket to the table were not fully engaged causing the table top to become unstable resulting in the reported event. The technician reinstalled the bolts properly securing the tilt cylinder bracket, tested the table, and confirmed it to be operating according to specification. While onsite, the technician counseled user facility personnel on proper preventive maintenance practices and no additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[117446925]
The user facility reported that the 3080sp surgical table began to tilt without being commanded during a patient procedure. The patient did not fall, and the procedure was completed successfully. No injuries were associated with the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2018-00064 |
| MDR Report Key | 7786569 |
| Date Received | 2018-08-15 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2018-07-18 |
| Date Added to Maude | 2018-08-15 |
| 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 | 3080SP SURGICAL TABLE |
| Generic Name | TABLE |
| Product Code | FWW |
| Date Received | 2018-08-15 |
| 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 | 2018-08-15 |