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

Device Problem Energy Output Problem (1431)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/23/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 317207075
• Report Number: 9616086-2023-00033
• Device Sequence Number: 1
• Product Code: IMG
• UDI-Device Identifier: 00888912294607
• UDI-Public: 00888912294607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male