MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA INTELECT SWD 100 PKG; DIATHERMY, SHORTWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number 1600

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

Health professional: unknown, occupation: unknown.The customer did not indicate that the device would be returned for evaluation; it was serviced by a third-party vendor.Additional information has been requested.If any additional information becomes available, a follow-up report will be submitted.

Event Description

It was reported that "the unit stopped working and was smoking".There was reportedly no patient injury.Further details have been requested.

• Brand Name: CHATTANOOGA INTELECT SWD 100 PKG
• Type of Device: DIATHERMY, SHORTWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• 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, b.c. 22244, ; MX
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8619281
• MDR Text Key: 145357204
• Report Number: 9616086-2019-00022
• Device Sequence Number: 1
• Product Code: IMJ
• UDI-Device Identifier: 00888912253772
• UDI-Public: 00888912253772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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