MAUDE Adverse Event Report: MEDTRONIC COVIDIEN DISPOSABLE CABLE AND LEAD WIRE S; DISPOSABLE CABLE AND LEAD SYSTEM

Catalog Number 33135T

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The disposable cable and lead wire system has been indicating inverted t waves when in reality they are not.The system was reported to clinical engineering this past week which they hooked it up to the simulator and it inverted the t wave there also.Apparently the anesthesia staff have been noticing this for quite time and have been sending the defective systems (33135) back to the company.No harm to pt, but may have caused unnecessary labs and/or diagnostic testing (troponin, ekg, etc) if two defective cables used.All 33135 systems removed.This system had the potential to plug the lead wire to trunk cable incorrectly.The company has replaced the 33135 system with the 33135t system.This system still has the potential to plug the trunk cable in to the monitor adaptor incorrectly.We have provided flyers/education for staff to make sure they get connected correctly (heart to heart).System tested using simulator.Diagnosis or reason for use: used to monitor pt's cardiac system.Event abated after use stopped or dose reduced? yes.Event reappeared after reintroduction? yes.

• Brand Name: COVIDIEN DISPOSABLE CABLE AND LEAD WIRE S
• Type of Device: DISPOSABLE CABLE AND LEAD SYSTEM
• Manufacturer (Section D): MEDTRONIC; boulder CO 80301
• MDR Report Key: 5445270
• MDR Text Key: 38648142
• Report Number: MW5060275
• Device Sequence Number: 2
• Product Code: LDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/12/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 33135T
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1