MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA VECTRA NEO; STIMULATOR, MUSCLE, POWERED

Model Number 6000

Device Problem Energy Output Problem (1431)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

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 intensity on electrostimulation jumps up without warning during treatment.There was reportedly no patient harm.

• Brand Name: CHATTANOOGA VECTRA NEO
• Type of Device: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• 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: 9354170
• MDR Text Key: 189885809
• Report Number: 9616086-2019-00083
• Device Sequence Number: 1
• Product Code: IPF
• UDI-Device Identifier: 00888912358743
• UDI-Public: 00888912358743
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132284
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2019
• 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