VECTORSURGE VS 200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-23 for VECTORSURGE VS 200 manufactured by Metron.

Event Text Entries

[16829845] Patient was being treated with interferential electrical stimulation. Four electrodes were placed on upper trapezivst sopraspinatos muscles. Intensity control would only reach 20 milliamps. Unit, electrode placement & contact were checked. Intensity was turned off & started again. Patient complained of burning sensation at 24 milliamps. Intensity was decreased to 16 milliamps and patient had no complaints. Treatment period was 15 minutes when electrodes were removed, 2 circular crythematous reactions were noted and two 3 mm blisters noted under other electrodes, 2nd & 3rd degree burns were diagnosed later that daydevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-may-92. Service provided by: distributor. Service records not available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 944
• MDR Report Key: 944
• Date Received: 1992-07-23
• Date of Report: 1992-07-13
• Date of Event: 1992-06-24
• Date Facility Aware: 1992-06-24
• Report Date: 1992-07-13
• Date Reported to FDA: 1992-07-13
• Date Added to Maude: 1992-07-29
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VECTORSURGE
• Generic Name: INTERFERENTIAL UNIT
• Product Code: LIH
• Date Received: 1992-07-23
• Model Number: VS 200
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-FEB-87
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 900
• Manufacturer: METRON

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-23