MAUDE Adverse Event Report: COVIDIEN 200 MEDI-TRACE 100/PK 1000/CA; ELECTRODE

Model Number 31050522

Device Problems False Reading From Device Non-Compliance (1228); Incorrect Interpretation of Signal (1543); Communication or Transmission Problem (2896)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/06/2016.An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a gauze pad.The customer reports: ecg electrode gives false reading, signal is difficult to interpret.

• Brand Name: 200 MEDI-TRACE 100/PK 1000/CA
• Type of Device: ELECTRODE
• Manufacturer (Section D): COVIDIEN; 215 herbert street; gananoque ; CA
• Manufacturer (Section G): COVIDIEN; 215 herbert street; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6004522
• MDR Text Key: 57090433
• Report Number: 9681860-2016-00008
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 31050522
• Device Catalogue Number: 31050522
• Device Lot Number: 602209X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1