MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-21 for VECTRA GENISYS 2789 manufactured by Chattanooga Group.
[785485]
Clinician was conducting electrotherapy treatment on the left shoulder area, when the pt began complaining of pain in the area of treatment. The clinician stopped the treatment. The pt did not suffer any known injury from the incident. The clinician treated the pt using the 4 pole interferential treatment (ifc). The ifc treatment was set up and applied with the device default settings. The device default setting for 4 pole ifc are output= constant voltage, carrier frequency = 4khz, frequency= 80/150hz. The treatment was applied with new electrodes. The clinician applied the treatment at level 30 volts, constant voltage. The clinician started the electrotherapy treatment and left the immediate area of the pt. The clinician indicated that the pt was holding the pt emergency switch. After an undetermined amount of time, the pt became distressed during the treatment and called for assistance. The clinician returned to the client and stopped the treatment. The clinician noted that the unit was initially set to deliver 30 volts, constant voltage. Upon returning to the distressed pt, the clinician noted that the unit delivery setting was at 90 volts, constant voltage. The pt did not suffer any injury.
Patient Sequence No: 1, Text Type: D, B5
[8026679]
Awaiting device return and eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00040 |
| MDR Report Key | 1006110 |
| Report Source | 05 |
| Date Received | 2008-02-21 |
| Date of Report | 2008-02-13 |
| Date of Event | 2008-01-24 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2008-04-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHEAL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VECTRA GENISYS |
| Generic Name | POWER MUSCLE STIMULATOR |
| Product Code | LIH |
| Date Received | 2008-02-21 |
| Model Number | 2789 |
| Catalog Number | 2789 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1001875 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-21 |