MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. MACVU 360 RESTING ECG ANALYSIS SYSTEM; ELECTROCARDIOGRAPH

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/10/2023

Event Type  Injury  

Manufacturer Narrative

Block a1 to a4: patient information not currently available.Block d4: udi: (b)(4).Ge healthcare investigation is ongoing.A follow up report will be submitted when the investigation has been completed.Legal manufacturer: hcs research park - 9900 innovation drive usa wauwatosa, wi 53226.H3 other text : device evaluation anticipated, but not yet begun.

Event Description

A patient was incorrectly treated due to use error.There was no malfunction with the device.

Manufacturer Narrative

Investigation findings: it was reported after conducting an ecg on patient a, the technician pressed â¿¿continue with same patientâ¿쳌, then pressed that again when patient b was connected 13 minutes later.The user completed patient b ecg without entering the patientâ¿¿s demographic information.The user mistakenly pressed â¿¿continue with same patientâ¿쳌 instead of "start new patient" which caused the ekg to attach to patient a demographics and lead to incorrect ecg results.The physician reviewed the ecg in muse and recommended a pacemaker for patient a based on patient b ecg.Patient a had a pacemaker placed unnecessarily.Based on the information available, gehcâs investigation concluded: (1) there were no indication of a device malfunction; (2) no design or user interface issues that may have contributed to the event and, (3) no adverse trend identified in a review of similar complaints.H3 other text : device problem already known, no evaluation necessary.

• Brand Name: MACVU 360 RESTING ECG ANALYSIS SYSTEM
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer (Section G): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer Contact: kristof soos ; 8200 w tower ave; milwaukee, WI 53223
• MDR Report Key: 17490467
• MDR Text Key: 320700357
• Report Number: 3008729547-2023-00005
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2023
• Date Device Manufactured: 08/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention