MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-06 for ARMEDICA HI-LO TREATMENT TABLE AM-BA300 manufactured by Armedica Mfg Corp.
[5683836]
Clinician states that their client was sitting in a chair next to the device and inadvertently rested her foot on the elevation control of the table, causing the table top frame to lower. The patient's leg became trapped between the top frame of the table and motor control, and the clinician was not able to stop the device in time to prevent injury to the patient's leg.
Patient Sequence No: 1, Text Type: D, B5
[13181512]
Although we suggested that an armedica representative visit their facility and examine all the armedica tables for the purpose of assuring they were safe and operating properly, the facility declined and said they were confident they had now properly serviced the tables and would not have any more issues in the future.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649977-2015-00001 |
| MDR Report Key | 4663603 |
| Report Source | 06 |
| Date Received | 2015-04-06 |
| Date of Report | 2015-02-28 |
| Date of Event | 2015-01-23 |
| Device Manufacturer Date | 2010-09-27 |
| Date Added to Maude | 2015-04-08 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL MCCORMICK |
| Manufacturer Street | 212 BELL RD |
| Manufacturer City | GREENWOOD AR 72936 |
| Manufacturer Country | US |
| Manufacturer Postal | 72936 |
| Manufacturer Phone | 4799962612 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARMEDICA HI-LO TREATMENT TABLE |
| Generic Name | HI-LO TREATMENT TABLE |
| Product Code | INQ |
| Date Received | 2015-04-06 |
| Model Number | AM-BA300 |
| Catalog Number | AM-BA300 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARMEDICA MFG CORP |
| Manufacturer Address | 212 BELL RD. P.O. BOX 880 GREENWOOD AR 72936 US 72936 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-06 |