MAUDE Adverse Event Report: 3M COMPANY NOVA PLUS; ELECTRODE, ELECTROCARDIOGRAPH

Model Number V2360

Device Problem Detachment Of Device Component (1104)

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

Event Date 10/30/2017

Event Type  malfunction  

Event Description

Resting electrocardiogram (ekg) electrodes were not sticking, falling off within seconds of being applied.(this happened multiple times, in several areas in the hospital and outpatient clinic).

• Brand Name: NOVA PLUS
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M COMPANY; 3m center, building 275-5w-06; st. paul MN 55144
• MDR Report Key: 7024218
• MDR Text Key: 91795086
• Report Number: 7024218
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: V2360
• Device Catalogue Number: V2360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2017
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1