MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2008-01-11 for INTELECT MOBILE 2CH STIM 2777 manufactured by Chattanooga Group.
[20239297]
The overstimulation occurred when the intensity was being increased at the start of the treatment. The unit was connected to a pt. No reported injury treatment and/or post injury treatment was reported by the complainant.
Patient Sequence No: 1, Text Type: D, B5
[20402995]
Previously investigated. Known potential shock and potential burn due to transient over-voltage within the circuitry causing components to fail and potentially shock or skin burn to the pt beneath the electrodes. Unit circuit boards were replaced onsite with preventive software.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00004 |
| MDR Report Key | 1026768 |
| Report Source | 01,08 |
| Date Received | 2008-01-11 |
| Date of Report | 2008-01-09 |
| Date of Event | 2007-07-26 |
| Date Mfgr Received | 2007-07-26 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2008-04-17 |
| 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 | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELECT MOBILE 2CH STIM |
| Generic Name | POWER MUSCLE STIMULATOR |
| Product Code | LIH |
| Date Received | 2008-01-11 |
| Model Number | 2777 |
| Catalog Number | 2777 |
| 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 | 994489 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-11 |