MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-11 for CHATTANOOGA 2783 manufactured by Djo Global.
[16183573]
A (b)(6) patient ordered to receive e-stim therapy s/p shoulder impingement syndrome. During a second round of e-stim therapy, the medical device stopped working (setting of 20pps). Upon restarting the device, the setting button jumped from 15pps to 50pps causing pain to the patient's shoulder. The device was turned off and a red mark was noted on the shoulder. No skin blistering noted, soft tissue massage and ice application to affected area provided relief. No adverse effect was ever reported and the patient subsequently returned for additional therapy. Complete inspection of device was done by the facility bio-med department and they reportedly were unable to replicate the event. It was then sent to the manufacturer and they reportedly were unable to replicate the event but replaced the keypad.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040775 |
| MDR Report Key | 4528316 |
| Date Received | 2015-02-11 |
| Date of Report | 2015-02-10 |
| Date of Event | 2014-11-03 |
| Date Added to Maude | 2015-02-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA |
| Generic Name | INTELECT TRANSPORT 2 CHANNEL |
| Product Code | GZI |
| Date Received | 2015-02-11 |
| Returned To Mfg | 2014-11-14 |
| Model Number | 2783 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO GLOBAL |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-11 |