MAUDE Adverse Event Report: BIO PROTECH INC. ELECTRODE, ECG, MONITORING, RT SNAP, REP; ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION

Model Number	E501RASR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was received and forwarded to the manufacturing facility for investigation.A follow up report will be filed when the investigation is completed.
Event or Problem Description
A patient reportedly sustained a burn from the monitoring electrodes when his mri was done.The patient had just come from the ed to the nursing unit.There was no serious injury, but some of the staff are reporting that they thought the electrodes didn't have metal so were okay to leave them on.
Additional Manufacturer Narrative
Based on the suppliers results of investigation, the device history record review did not indicate any exception that could lead to the reported incident. no changes to the product specifications have been made per the supplier. the supplier has tested retained electrodes and determined that they are safe for use for mri scans. a general consideration when working with mri scans is that any conductive material, which will be inside the scan and in contact or close to the patient during scan, should not form conductive loops.This means that for example, the electrode wires should not be placed forming a loop.If the wires are forming a loop, the strong magnetic field of the scanner will generate an electric current in the wires that will heat the electrodes and consequently burn the patient¿s skin.  as a sample was not available for the investigation, the root cause for the reported issue could not be determined. at this time no additional action will be taken.

• Brand Name: ELECTRODE, ECG, MONITORING, RT SNAP, REP
• Common Device Name: ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
• Manufacturer (Section D): BIO PROTECH INC.; donghwas med. inst. comp.151-3; dongwagongdan-ro, munmak-eup; wonju-si, ganwon-do 220-8 01; KS 220-801
• MDR Report Key: 6647749
• Report Number: 1423537-2017-00108
• Device Sequence Number: 11050187
• Product Code: MLN
• UDI-Device Identifier: 00885380048398
• UDI-Public: 00885380048398
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2017
• Report Date (Section F): 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E501RASR
• Device Catalogue Number: E501RASR
• Device Lot Number: 170210G
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/19/2017
• Date Report to Manufacturer: 06/16/2017
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 07/05/2017
• Patient Sequence Number: 1