MAUDE Adverse Event Report: MORTARA INSTRUMENT BUR280 STD WITH AM12 DICOM; ELECTROCARDIOGRAPH

Model Number BUR280-C1D

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Data Problem (3197)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

The eli 280 is a 12-lead electrocardiograph device intended to be used to perform 12 lead resting ecgs.The acquired data can be reviewed, stored, printed, and/or transmitted to an emr system.The eli 280 resting electrocardiograph is indicated for use to acquire, analyze, display, and print electrocardiograms.Device is indicated for use to provide interpretation of the data for consideration by a physician.Device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician.It is not intended as a sole means of diagnosis.The interpretations of ecg offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.Device is indicated for use on adult and pediatric populations.The device is not intended to be used as a vital signs physiological monitor.The hrc technician remotely investigated the reported event but was not able to reproduce the issue.Hillrom is sending the hrc technician on site to further investigate the reported malfunction.Hillrom will submit a supplemental report with findings once the on site repair has been completed.The inability to delete an ecg exam may be inconvenient to the user but it would not be likely to lead to serious injury or death and would not be considered a reportable malfunction.Although there was no patient harm reported in this case, an incorrect association of ecg records with wrong patient charts could lead to misdiagnosis and/or mistreatment which could ultimately lead to patient harm, therefore, hillrom considers this complaint reportable.

Event Description

The customer reported having issues on the eli280 which began after installing software version 2.4.1.8 it was reported that when the staff selected "erase" to erase an ekg, it remained in the directory and the wrong patient demographics were on the ekg printout.This incident was captured under hillrom complaint ref # (b)(4).

Event Description

The customer reported having issues on the eli280 which began after installing software version 2.4.1.8 it was reported that when the staff selected "erase" to erase an ekg, it remained in the directory and the wrong patient demographics were on the ekg printout.This incident was captured under hillrom complaint ref # (b)(4).

Manufacturer Narrative

The eli 280 is a 12-lead electrocardiograph device intended to be used to perform 12 lead resting ecgs.The acquired data can be reviewed, stored, printed, and/or transmitted to an emr system.The eli 280 resting electrocardiograph is indicated for use to acquire, analyze, display, and print electrocardiograms.Device is indicated for use to provide interpretation of the data for consideration by a physician.Device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician.It is not intended as a sole means of diagnosis.The interpretations of ecg offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.Device is indicated for use on adult and pediatric populations.The device is not intended to be used as a vital signs physiological monitor.Additional troubleshooting was performed by the hillrom engineer with the customer.It was determined that the user went into the ecg directory and selected the wrong patient.The directory is where ecgs that have already been taken are stored.This was user error according to the customer.The customer was provided training on how to correctly use the patient directory to prevent this reported event from reoccurring.Based on this information no further actions are necessary.

• Brand Name: BUR280 STD WITH AM12 DICOM
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16173233
• MDR Text Key: 308833086
• Report Number: 2183461-2023-00002
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00812345024913
• UDI-Public: 812345024913
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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 Model Number: BUR280-C1D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/16/2023
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1