MAUDE Adverse Event Report: COVIDIEN COVIDIEN ADAPTER

Model Number REF 33541

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/18/2017

Event Type  malfunction  

Event Description

Telemetry monitor showed ventricular tachycardia.When pt was attached to defibrillator the rhythm showed normal sinus rhythm.Telemetry monitor continued to show ventricular tachycardia.Telemetry monitor, leads and pads were changed and rhythm then showed normal sinus rhythm.

• Brand Name: COVIDIEN ADAPTER
• Type of Device: ADAPTER
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 6360793
• MDR Text Key: 68526932
• Report Number: MW5068138
• Device Sequence Number: 1
• Product Code: DRW
• 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: 02/23/2017

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
• Device Operator: Health Professional
• Device Model Number: REF 33541
• Device Catalogue Number: 33541
• Device Lot Number: 278428
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 114