MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-12-20 for OT1200 TABLE manufactured by Steris Corporation - Montgomery.
[3981391]
The user facility reported that during a procedure an ot1200 surgical table was not operating properly. No injuries were reported. No procedural delays or cancellations occurred.
Patient Sequence No: 1, Text Type: D, B5
[11387376]
Investigation remains in process; a follow-up report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2013-00137 |
| MDR Report Key | 3531216 |
| Report Source | 06 |
| Date Received | 2013-12-20 |
| Date of Report | 2013-12-20 |
| Date of Event | 2013-11-20 |
| Date Mfgr Received | 2013-11-20 |
| Date Added to Maude | 2014-03-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| 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 | 3 |
| Brand Name | OT1200 TABLE |
| Generic Name | SURGICAL TABLE |
| Product Code | JEB |
| Date Received | 2013-12-20 |
| 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 | 2013-12-20 |