MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-04 for ORTHOVISION TABLE manufactured by Steris Corporation - Montgomery.
[3260893]
The user facility reported that during a patient procedure the patient indicated that she felt like she was going to fall off the table. Nursing staff experienced difficulty in keeping the patient on the table and repeatedly had to reposition the patient. No injury to the patient or hospital staff. No procedural delays or cancellations reported.
Patient Sequence No: 1, Text Type: D, B5
[10616292]
At the time of the purchase of the table the user facility also purchased the standard accessory package. Following the arrival of the table the user facility staff received in-service training. The standard accessory package does not include a lateral brace. The orthovision setup guide states:" advisory- the illustrations in this brochure are intended to provide general guidance on table setup and patient positioning for the surgical procedures shown. Actual circumstances and the patients' medical conditions may necessitate modifications which much by made in accordance with good medical practice. " the setup guide further states: "warning-prevent possible patient or user injury-always secure patient for the surgery being performed in accordance with good medical practice appropriate patient restraints. Patient restraints are either not identified or have not been show in the accompanying illustrations. " the user facility has placed an order to purchase a set of lateral braces and steris conducted an in-service training during the week of (b)(4) 2013. During steris' visit to the user facility during the week of (b)(4) 2013 it was confirmed that the table was found to be operating properly; no issues were noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2013-00032 |
| MDR Report Key | 3036207 |
| Report Source | 06 |
| Date Received | 2013-04-04 |
| Date of Report | 2013-04-04 |
| Date of Event | 2013-01-07 |
| Date Mfgr Received | 2013-03-05 |
| Date Added to Maude | 2013-04-04 |
| 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 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 | SURGICAL TABLE |
| Product Code | JEB |
| Date Received | 2013-04-04 |
| 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 | 1. Other | 2013-04-04 |