MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-04 for CMAX SURGICAL TABLE manufactured by Steris Corporation - Montgomery.
[184985930]
A steris service technician arrived onsite following the reported event to inspect the cmax surgical table and found that wire from the battery fuse assembly was damaged. The user facility has opted to not repair the surgical table at this time and the table currently remains out of service. The cmax surgical table was placed into service in 2009 making it approximately 11 years old and is serviced and maintained by the user facility. The user facility did not disclose when the last preventive maintenance was completed for the table. The steris service technician counseled the user facility on the importance of regular preventive maintenance on their steris products. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[184985931]
The user facility reported that after smelling smoke from the hallway, an employee found that their cmax surgical table had caught fire. A patient was not present on the table during the time of the reported event. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2020-00016 |
| MDR Report Key | 9788767 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 3927453 |
| Manufacturer G1 | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY, AL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CMAX SURGICAL TABLE |
| Generic Name | SURGICAL TABLE |
| Product Code | GDC |
| Date Received | 2020-03-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY, AL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |