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

Model Number 6000

Device Problem Power Conditioning Problem (1474)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2019

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 upon increasing the intensity, while set on stimulation, the unit raises all the way to its maximum.The unit was quickly turned off and there was reportedly no patient harm.No further information is currently available.

• Brand Name: CHATTANOOGA VECTRA NEO
• Type of Device: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c.
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 9225565
• MDR Text Key: 208332472
• Report Number: 9616086-2019-00076
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• 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: 09/28/2019
• 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