MAUDE Adverse Event Report: DJO LLC VECTRA GENISYS 4CH COMBO US STD W/CART; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number	2796
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported the unit automatically shuts off when the intensity is above 40 and happens ever 5-10 minutes.It was also reported that a patient allegedly received a 2nd degree burn.The actual device was returned, but too damaged to perform any type of evaluation.
Event or Problem Description
It was reported the unit automatically shuts off when the intensity is above 40 and happens ever 5-10 minutes.It was also reported that a patient allegedly received a 2nd degree burn.

• Brand Name: VECTRA GENISYS 4CH COMBO US STD W/CART
• Common Device Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; suite 200; carlsbad CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 2900 lake vista drive; suite 200; lewisville, TX 75067 ; 5126088462
• MDR Report Key: 17131890
• Report Number: 9616086-2023-00033
• Device Sequence Number: 12383940
• Product Code: IMG
• UDI-Device Identifier: 00888912294607
• UDI-Public: 00888912294607
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K031077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male