MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-02-28 for ORTHOVISION TABLE manufactured by Steris Corporation - Montgomery.
[17131559]
The user facility reported that when a patient is placed on the orthovision table it would slowly drift down. No injuries or procedural delays/cancellations reported.
Patient Sequence No: 1, Text Type: D, B5
[17358239]
A steris service technician inspected the table and found that the table top would drift slowly down due to leakage within the lift cylinder when patient weight was applied. The user facility stated to the steris technician that they were aware of the need to repair the table but continued to use it. The technician stated that they were using some unspecified means of blocking/stopping the table drift. The technician replaced the lift cylinder, tested the table and confirmed it to be operational. The table is not under steris service contract and is serviced and maintained by the user facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2013-00017 |
| MDR Report Key | 2983211 |
| Report Source | 06 |
| Date Received | 2013-02-28 |
| Date of Report | 2013-02-28 |
| Date of Event | 2013-01-29 |
| Date Mfgr Received | 2013-01-29 |
| Date Added to Maude | 2013-05-09 |
| 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 | TABLE |
| Product Code | JEB |
| Date Received | 2013-02-28 |
| 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 | 2013-02-28 |