MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2011-07-28 for MIDMARK 630 manufactured by Midmark Corp..
[21424436]
A staff member was using the foot section of the table as a writing surface with their legs positioned below the foot section. The staff inadvertently pressed the home position button on the foot control which moved the foot section onto their legs causing bruising.
Patient Sequence No: 1, Text Type: D, B5
[21518697]
The device operated as intended. The instructions for use cautions the operator to be sure that all personnel and equipment care clear of the table before activating any function.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2011-00022 |
| MDR Report Key | 2197732 |
| Report Source | 01,06,07 |
| Date Received | 2011-07-28 |
| Date of Report | 2011-07-27 |
| Date of Event | 2011-07-04 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2012-05-15 |
| 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 | DONALD CARR |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375263662 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDMARK |
| Generic Name | CHAIR, SURGICAL, AC-POWERED |
| Product Code | GBB |
| Date Received | 2011-07-28 |
| Model Number | 630 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-28 |