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

Model Number 39-0700

Device Problems Fire (1245); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

Not returned.

Event 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.

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
• Type of Device: DIRECT SUPPLY PANACEA SHORTWAVE DIATHERMY DEVICE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663 ; 7607313126
• MDR Report Key: 6324830
• MDR Text Key: 67204781
• Report Number: 9616086-2017-00003
• Device Sequence Number: 1
• Product Code: IMJ
• UDI-Device Identifier: 00888912335645
• UDI-Public: 00888912335645
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: KO83433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 39-0700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other