MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI280 AM12 AHA BAN WLAN USBD DICOM SEC; ELI280 WAM AHA BAN WLAN USBD DICOM

Model Number	ELI280-AAA-AAFBT
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
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 device was returned for repair where it failed the functional check and it was determined that the issue was with the mainboard; the drive gear screw was loose on the printer transmission.The hrc technician reset the screw and torqued to spec using loctite.The device was evaluated, and safety tested and was functioning as designed.Ecgs are routinely performed to diagnose cardiac problems and there are no risks associated with the test itself, however, there is a risk of associating ecg records with wrong patients leading to misdiagnosis and incorrect treatment.For this reason, hillrom determines this event reportable.
Event or Problem Description
The customer reported that the eli280 unit will have an incorrect patient displayed after taking an ecg.This event has been captured under hillrom complaint ref # (b)(4).

• Brand Name: ELI280 AM12 AHA BAN WLAN USBD DICOM SEC
• Common Device Name: ELI280 WAM AHA BAN WLAN USBD DICOM
• 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: 15337649
• Report Number: 2183461-2022-00035
• Device Sequence Number: 17752018
• Product Code: DPS
• UDI-Device Identifier: 00817655020709
• UDI-Public: 817655020709
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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-AAA-AAFBT
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown