MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-02-11 for CHATTANOOGA 39-0700 manufactured by Djo, Llc.
[67204781]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[67204782]
Complaint received that alleges "(b)(6) we received a report of broken cables on the unit and a note that the customer had used duct tape to repair them. I asked for more information and did not receive a response until (b)(6) stating that the unit had caught fire". Questionnaire not received from customer or clinician. Device not returned to manufacturer for evaluation. No indication event caused or contributed to serious injury, permanent impairment or death.
Patient Sequence No: 1, Text Type: D, B5
[71248318]
Product was returned for review. When unpacked unit was well packed, but had several parts broken like bottom drawer, top display back cover was broken, monode one side terminal pin was broken. Unit monode (02200002) was tested for continuity and pass but still the monode one side terminal was broken so unable to connect it to unit; unit was tested as is and after 30 seconds running at level # 4 with 150 watts output the unit digital monitor display showed: "information # 119" making references to checking the electrodes and will not operate normally. Root cause: monode one side terminal broke off.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2017-00003 |
| MDR Report Key | 6324830 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-02-11 |
| Date of Report | 2017-03-29 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-03-29 |
| Date Added to Maude | 2017-02-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607313126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA |
| Generic Name | DIRECT SUPPLY PANACEA SHORTWAVE DIATHERMY DEVICE |
| Product Code | IMJ |
| Date Received | 2017-02-11 |
| Model Number | 39-0700 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-11 |