MAUDE Adverse Event Report: NULL; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 21-0461-51

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2021

Event Type  malfunction  

Event Description

It was reported that ecg leads not working, not giving reading.Tried other ecg leads and the other ecg leads work with the monitor.The cable works as well, so it appears to just be the leads.No adverse patient effects were reported.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-10479.The report was submitted in error.

• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section G): NULL
• MDR Report Key: 12725420
• MDR Text Key: 280532546
• Report Number: 3012307300-2021-10479
• 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: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-0461-51
• Device Catalogue Number: 21-0461-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1