MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-02-04 for INTELECT TRANSPORT ULTRASOUND 2782 manufactured by Chattanooga Group.
[984222]
The patient was receiving an ultrasound treatment when they reported feeling a shock sensation. The clinician reported that the treatment intensity was set to 1. 5 watts per centimeter squared. The patient was being treated in the neck area for pain. No other treatment details could be provided.
Patient Sequence No: 1, Text Type: D, B5
[8170635]
A device evaluation was performed by our engineering department. Root cause is unknown because the device performed to specification, and to its intended use. The engineering department did not find any problems with the device. (see scanned pages).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2009-00022 |
| MDR Report Key | 1305367 |
| Report Source | 05 |
| Date Received | 2009-02-04 |
| Date of Report | 2009-01-13 |
| Date of Event | 2008-12-12 |
| Date Mfgr Received | 2009-01-13 |
| Date Added to Maude | 2009-02-11 |
| 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 | INTELECT TRANSPORT ULTRASOUND |
| Product Code | GZI |
| Date Received | 2009-02-04 |
| Returned To Mfg | 2009-01-15 |
| Model Number | 2782 |
| Catalog Number | 2782 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-02-04 |