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

Model Number 6000

Device Problem Intermittent Energy Output (4025)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Health professional: unknown.Occupation: unknown.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 "e-stim machine is jumping with the current being delivered.Customer does not get any error code and unit does not stop treatment.Therefore, safety feature fail to activate." there was no reported 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: 9529951
• MDR Text Key: 198560956
• Report Number: 9616086-2019-00089
• 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: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 12/10/2019
• 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