MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-10-02 for AMBA240 manufactured by Armedica Mfg. Corp..
[27623030]
Inspection still pending. Service tech to make appointment with facility.
Patient Sequence No: 1, Text Type: N, H10
[27623031]
Pt was sitting on a chair next to the hi-lo table. He placed his foot on the bar activator and the table began to lower. The therapist saw the table lowering and told the pt to move his leg. The pt did not respond. The table lowered onto the pts knee. This resulted in a fractured ankle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649977-2015-00003 |
| MDR Report Key | 5130875 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-10-02 |
| Date of Report | 2015-09-15 |
| Date of Event | 2015-08-20 |
| Date Mfgr Received | 2015-09-09 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2015-10-06 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 212 BELL RD. PO BOX 880 |
| Manufacturer City | GREENWOOD AR 72936 |
| Manufacturer Country | US |
| Manufacturer Postal | 72936 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AMBA240 |
| Generic Name | AMBA240 |
| Product Code | INQ |
| Date Received | 2015-10-02 |
| Model Number | AMBA240 |
| Catalog Number | AMBA240 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARMEDICA MFG. CORP. |
| Manufacturer Address | GREENWOOD AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-10-02 |