MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-02-05 for DYNATRON D650 manufactured by Dynatronics.
[3140919]
On (b)(6) 2013, dynatronics received a phone call from a medical device dealer reporting that they were contacted by an end user facility regarding two dynatronics devices (d650; d650 plus) that were involved in two adverse events involving two different patients. The end user facility was asked to complete an incident questionnaire for each of the adverse events but would not provide any details as to what had occurred with the devices. The only details that were made known to the dealer are that one of the events required medical intervention; the other event did not require medical intervention. It is not known which device was involved in the event that resulted in medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[10479271]
There were no problems found with the operation of the device. All outputs from the device were within specifications. Chassis ground leakage test was within specifications. Patient leads and power cord tested good. Device has current software and all routine equipment maintenance items have been previously implemented. The overlay (user-device interface) was evaluated and it was found to be in good condition. Labeling for the device was evaluated and the operator's manual contains industry standard contra indications, warnings, and precautions for all modalities available on the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719362-2013-00002 |
| MDR Report Key | 2960644 |
| Report Source | 08 |
| Date Received | 2013-02-05 |
| Date of Report | 2013-02-05 |
| Date of Event | 2013-01-11 |
| Date Mfgr Received | 2013-01-11 |
| Device Manufacturer Date | 1995-09-01 |
| Date Added to Maude | 2013-03-01 |
| 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 | VINCE FOGER |
| Manufacturer Street | 7030 PARK CENTRE DR. |
| Manufacturer City | COTTONWOOD HEIGHTS UT 84121 |
| Manufacturer Country | US |
| Manufacturer Postal | 84121 |
| Manufacturer Phone | 8008746251 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNATRON D650 |
| Generic Name | ELECTROTHERAPY |
| Product Code | IMG |
| Date Received | 2013-02-05 |
| Returned To Mfg | 2013-01-25 |
| Model Number | D650 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DYNATRONICS |
| Manufacturer Address | 7030 PARK CENTRE DR. COTTONWOOD HEIGHTS UT 84121 US 84121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-05 |