MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-15 for METRON ELITE ASTER ELECTRIC W/UP-DOWN T8718NT9009 manufactured by Metron Medical Co.,ltd.
[36033677]
Patient Sequence No: 1, Text Type: N, H10
[36033678]
We are not aware of any patient, staff or visitor injuries related to these tables. We are, however, concerned that the lifting/lowering mechanism's design could result in entrapment and injuries. There is nothing to prevent the device from halting its movement path if there was an entrapment. This mechanism operates in a similar fashion to another manufacturer's device that operates in the same fashion. The table lowers when the foot pedal is depressed and there is no sensor to stop the bed of a limb is subsequently entrapped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5369293 |
| MDR Report Key | 5369293 |
| Date Received | 2016-01-15 |
| Date of Report | 2016-01-12 |
| Date of Event | 2016-01-01 |
| Report Date | 2016-01-05 |
| Date Reported to FDA | 2016-01-05 |
| Date Reported to Mfgr | 2016-01-05 |
| Date Added to Maude | 2016-01-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | METRON ELITE ASTER ELECTRIC W/UP-DOWN |
| Generic Name | POWERED TABLE |
| Product Code | INQ |
| Date Received | 2016-01-15 |
| Model Number | T8718NT9009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METRON MEDICAL CO.,LTD |
| Manufacturer Address | W68 N158 EVERGREEN BLVD. CEDARBURG, WI 53012 US 53012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-15 |