MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; DIRECT SUPPLY PANACEA SHORTWAVE DIATHERMY DEVICE

Model Number	39-0700
Medical Device Problem Codes	Fire (1245); Device Inoperable (1663)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not returned.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: CHATTANOOGA
• Common Device Name: DIRECT SUPPLY PANACEA SHORTWAVE DIATHERMY DEVICE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 6324830
• Report Number: 9616086-2017-00003
• Device Sequence Number: 13597572
• Product Code: IMJ
• UDI-Device Identifier: 00888912335645
• UDI-Public: 00888912335645
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: KO83433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 39-0700
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2017
• Supplement Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other