MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-12-21 for ORTHOVISION TABLE manufactured by Steris Corporation - Montgomery.
[17465249]
Reference medwatch (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[17708917]
A steris service technician inspected the surgical table and found it to be operating to specifications. The steris account manager visited the customer and provided them with a replacement copy of the orthovision tables setup guide and reviewed with them the patient restraint's that are available for use with this table. The operator manual for the orthovision table also warns that healthcare professionals must ensure the patient is secured to the table in accordance with recommended positioning practices (pg. 1-2). Steris provides suggested guidelines, however, the guidelines do not replace good medical practices and common patient positioning techniques used clinically.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2012-00102 |
| MDR Report Key | 2883670 |
| Report Source | 06 |
| Date Received | 2012-12-21 |
| Date of Report | 2012-12-21 |
| Date of Event | 2012-07-05 |
| Date Mfgr Received | 2012-11-29 |
| Date Added to Maude | 2013-03-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS LINDSEY MCGOWAN |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927519 |
| 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 | ORTHOVISION TABLE |
| Generic Name | ORTHOVISION TABLE |
| Product Code | JEB |
| Date Received | 2012-12-21 |
| 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 | 2012-12-21 |