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

Model Number 6000

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 06/29/2020

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 device shocked a patient while in electrotherapy treatment.Device not received manufacturer at this time.Manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

• Brand Name: CHATTANOOGA VECTRA NEO
• Type of Device: STIMULATOR, MUSCLE, POWERED,
• Manufacturer (Section D): DJO LLC.; 1430 decision street; vista, ca
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S. A. DE C. V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c., mx 22244 ; MX 22244
• Manufacturer Contact: christine bonczyk ; 2900 lake vista drive; lewisville, tx
• MDR Report Key: 10326535
• MDR Text Key: 200431515
• Report Number: 9616086-2020-00025
• Device Sequence Number: 1
• Product Code: IPF
• UDI-Device Identifier: 00888912358743
• UDI-Public: 00888912358743
• Combination Product (y/n): N
• PMA/PMN Number: K132284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6000
• Date Manufacturer Received: 06/29/2020
• 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