MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-12-15 for VECTRA GENISYS 4CH COMBO 2761 manufactured by Chattanooga Group.
[991029]
The pt alleged receiving an un-intended output during an electrotherapy treatment. The pt was being treated with the vms burst waveform. The selected protocol and parameters include a 2 second ramp, verse frequency of 5, 15 min cycle, 200 uses, cycle 5/5 for bilateral muscle spasm control. The tech had applied 4 - 2 3/4" electrodes to the pt's back. As the tech turned up the device, the pt rec'd a shock. The pt reported that the shock was short in duration. The pt's progression was not impeded as a result of the incident.
Patient Sequence No: 1, Text Type: D, B5
[8136362]
This alleged incident is currently under investigation. Future results and findings will be communicated to the fda via the form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00357 |
| MDR Report Key | 1266230 |
| Report Source | 05 |
| Date Received | 2008-12-15 |
| Date of Report | 2008-11-21 |
| Date of Event | 2008-11-19 |
| Date Mfgr Received | 2008-11-21 |
| Date Added to Maude | 2009-01-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL 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 4CH COMBO |
| Generic Name | IPF, IMG, GZJ, HCC, GZI |
| Product Code | GZI |
| Date Received | 2008-12-15 |
| Returned To Mfg | 2008-12-01 |
| Model Number | 2761 |
| Catalog Number | 2761 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-12-15 |