MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI280 WAM AHA BAN WLAN USBD DICOM; ELECTROCARDIOGRAPH

Model Number ELI280-CAA-AAFBD

Device Problem Patient Data Problem (3197)

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

Event Date 08/19/2022

Event Type  malfunction  

Event Description

The customer reported that they¿ve noticed some ecg tests were being attached to the wrong patients¿ chart.There was no report of patient harm.This event was captured under hill-rom 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a vital signs physiological monitor.The hrc technician investigated the reported issue and found that it was due to an out of date version of the device¿s software.Hillrom became aware of this potential issue with the software and issued a software update with fsca 2021-07-001-mke-005 in 2021.A search of our database revealed that the customer was notified and provided response form on (b)(6)2021, but we don¿t have confirmation that the software was actually downloaded.A new letter including the link to download the software was sent to the customer to resolve this issue.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.

• Brand Name: ELI280 WAM AHA BAN WLAN USBD 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: 15401311
• MDR Text Key: 304462726
• Report Number: 2183461-2022-00037
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00812345026252
• UDI-Public: 812345026252
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2022

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: ELI280-CAA-AAFBD
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1