MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-03 for ULTRA HIGH/LOW TABLE manufactured by Dynatronics.
[74631225]
No incident with a patient. However, on multiple occasions the ultra high/low table would raise on its own after the therapist removed their foot from the foot plate. According to the therapist, no patients have actually been on the table when this has occurred.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5069574 |
MDR Report Key | 6547335 |
Date Received | 2017-05-03 |
Date of Report | 2017-05-03 |
Date Added to Maude | 2017-05-05 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
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 | 0 |
Brand Name | ULTRA HIGH/LOW TABLE |
Generic Name | TABLE, POWERED |
Product Code | INQ |
Date Received | 2017-05-03 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | DYNATRONICS |
Manufacturer Address | US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-05-03 |