MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-06-19 for CHATTANOOGA 02200002 manufactured by Gbo Medizintechnik Ag.
[5812699]
Complaint received from customer that alleges "monode smoking, has a burning smell". Questionnaire was not received from clinician and/or pt. Device not returned to manufacturer for eval. No indication event caused or contributed to permanent impairment or death. No indication device caused or contributed to the event.
Patient Sequence No: 1, Text Type: D, B5
[41752801]
Fda acknowledged recall #z-0121-2016 in process as a result of this and similar incidences.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2015-00015 |
| MDR Report Key | 4861665 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-06-19 |
| Date of Report | 2016-04-04 |
| Date of Event | 2015-06-04 |
| Date Added to Maude | 2015-07-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM FISHER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607313126 |
| Manufacturer G1 | GBO MEDIZINTECHNIK AG |
| Manufacturer Street | KLEISTSTRASSE 6 |
| Manufacturer City | RIMBACH C-64668 |
| Manufacturer Postal Code | C-64668 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA |
| Generic Name | MONODE |
| Product Code | IMJ |
| Date Received | 2015-06-19 |
| Model Number | 02200002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GBO MEDIZINTECHNIK AG |
| Manufacturer Address | KLEISTRASSE 6 RIMBACH C-64668 C-64668 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-19 |