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

Model Number	ELI280-CAA-AAFBD
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Additional 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a vital signs physiological monitor.The hrc technician investigated the reported issue and found that it was due to an out of date version of the device¿s software.Hillrom became aware of this potential issue with the software and issued a software update with fsca 2021-07-001-mke-005 in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.
Event or Problem 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 has been captured under hillrom complaint ref#: (b)(4).

• Brand Name: ELI280 WAM AHA BAN WLAN USBD DICOM
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15390899
• Report Number: 2183461-2022-00036
• Device Sequence Number: 17667882
• Product Code: DPS
• UDI-Device Identifier: 00812345026252
• UDI-Public: 812345026252
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown