MAUDE Adverse Event Report: DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. CHATTANOOGA INTELECT TRANSPORT COMBO PKG US STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number 2738

Device Problem Intermittent Energy Output (4025)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the unit experienced "lite shocking intensity skips, issue with encoder and knob no error codes" during treatment.There was reportedly no injury to the patient.

• Brand Name: CHATTANOOGA INTELECT TRANSPORT COMBO PKG US STD
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• 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 22244
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 9510520
• MDR Text Key: 208331503
• Report Number: 9616086-2019-00086
• Device Sequence Number: 1
• Product Code: IMG
• UDI-Device Identifier: 00888912021883
• UDI-Public: 00888912021883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1