MAUDE Adverse Event Report: CHATTANOOGA GROUP VECTRA GENISYS 2 CH; POWER MUSCLE STIMULATOR

Model Number VECTRA GENISYS 2761

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fluid Discharge (2686); No Code Available (3191)

Event Date 07/13/2016

Event Type  malfunction  

Event Description

Patient arrived for her 4:00pm physical therapy treatment appointment.While on the sci-fit seated stepper, patient informed physical therapist of superficial wound on her l lower back/flank area that she and her son noticed late that evening a few days earlier.Patient and son reported that after physical therapy that day (~6pm), they went do some errands and went home and noticed the localized discolored area on l lower back/flank.The patient's son states they put neosporin on it and it seems to have scabbed over on the weekend; pt denied pain on or around the same area throughout the weekend.Upon inspection, the physical therapist noted a 1.0 inch by 0.5 inch oval shaped wound with clean edges and black slough, (-) drainage, (-) erythema on left lower back/flank region.Pt denied pain on wound or periphery upon ocular inspection and palpation around the lower back region.Review showed it is approximately around the area where the electrode pads for the interferential current modality was placed on pt's last treatment.Physical therapist called rehab manager to inform her of incident.Rehab manager arrived and inspected the area as well as interviewed the patient and son about the incident.Manufacturer response for electrical stimulator machine, vectra genisys (per site reporter): reported by mgr of rehab.Manufacturer escalated the event to the regional mgr.Currently awaiting response.

Event Description

Patient arrived for her 4:00pm physical therapy treatment appointment.While on the sci-fit seated stepper, patient informed physical therapist of superficial wound on her l lower back/flank area that she and her son noticed late that evening a few days earlier.Patient and son reported that after physical therapy that day (~6pm), they went to do some errands and went home and noticed the localized discolored area on l lower back/flank.The patient's son states they put neosporin on it and it seems to have scabbed over on the weekend; pt denied pain on or around the same area throughout the weekend.Upon inspection, the physical therapist noted a 1.0 inch by 0.5 inch oval shaped wound with clean edges and black slough, (-) drainage, (-) erythema on left lower back/flank region.Pt denied pain on wound or periphery upon ocular inspection and palpation around the lower back region.Review showed it is approximately around the area where the electrode pads for the interferential current modality was placed on pt's last treatment.Physical therapist called rehab manager to inform her of incident.Rehab manager arrived and inspected the area as well as interviewed the patient and son about the incident.Manufacturer response for electrical stimulator machine, vectra genisys (per site reporter).Reported by mgr of rehab.Manufacturer escalated the event to the regional mgr.¿ currently awaiting response.

• Brand Name: VECTRA GENISYS 2 CH
• Type of Device: POWER MUSCLE STIMULATOR
• Manufacturer (Section D): CHATTANOOGA GROUP; 1430 decision st.; vista, CA 92081
• MDR Report Key: 5885336
• MDR Text Key: 52409988
• Report Number: 5885336
• Device Sequence Number: 1
• Product Code: IPF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VECTRA GENISYS 2761
• Device Catalogue Number: 2761
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2016
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 81