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U.S. Department of Health and Human Services

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

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DJO, LLC CHATTANOOGA VECTRA NEO STIMULATOR, MUSCLE, POWERED Back to Search Results
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.

 
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Brand NameCHATTANOOGA VECTRA NEO
Type of DeviceSTIMULATOR, 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 Key9354148
MDR Text Key189885235
Report Number9616086-2019-00082
Device Sequence Number1
Product Code IPF
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 11/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2019
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 Unkown

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