MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-02 for RITTER 222-015 manufactured by Midmark Corp..
[4768380]
A pediatric pt was lowering the table while unattended by a medical professional and the foot switch was on the tables base and under the drawer. The table lowered to the point where the drawer pinned the pt's foot between itself and the base. The pt sustained an injury to their foot.
Patient Sequence No: 1, Text Type: D, B5
[12244435]
It was found that the pt was using the foot control under the drawer section on top of the tables base while unattended. The tables users guide clearly states: "caution: be sure that all personnel and equipment are clear of the table before activating any function. Failure to do so could result in personal injury. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2012-00024 |
| MDR Report Key | 4146689 |
| Report Source | 05,06 |
| Date Received | 2012-08-02 |
| Date of Report | 2012-08-02 |
| Date of Event | 2012-07-06 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2014-10-08 |
| 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 | CRAIG RAMMEL |
| 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 | RITTER |
| Generic Name | CHAIR, SURGICAL, AC-POWERED |
| Product Code | GBB |
| Date Received | 2012-08-02 |
| Model Number | 222-015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-08-02 |