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 09/16/2021

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 investigation to determine the root cause of this event is ongoing and confirmation of user workflow is pending.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.No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

The customer reported she went to complete an ekg.When she turned the cart on, there was an ekg tracing on the cart.She transmitted the ekg.After she transmitted, she went to enter the demographic and another patient's information was already in the demographic fields.She manually deleted all the previous patient's demographics before she could enter the current patient.The ekg of the patient whose demographics were found to have transmitted 2 times at approx 2.5 minutes apart, both coming from the same cart.This report was filed in our complaint handling system as complaint # (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 investigation to determine the root cause of this event is ongoing and confirmation of user workflow is pending.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 am12 is a wired system used to acquire electrocardiographic data.They perform integrated data conversion and patient isolation and acquire cardiac-related electrical signals from a patient's body and transmits these signals to a host system for processing and representation as an electrocardiogram.They are used with stress testing system, resting ecgs, and patient monitors.The hrc technician investigated the device thoroughly and could not replicate the reported issue.Possible scenarios with the am12 that might result in a problem were run , but none yielded any failure.The scenario as reported was reproduced as closely as possible with 240 exams.This also did not result in any issues.No malfunction.There was no serious incident reported and should this incident recur, it is unlikely to cause or contribute to a serious incident for the reasons stated above.Therefore, hillrom does not consider this complaint reportable.Based on this information, no further action is required.

Event Description

The customer reported she went to complete an ekg.When she turned the cart on, there was an ekg tracing on the cart.She transmitted the ekg.After she transmitted, she went to enter the demographic and another patient's information was already in the demographic fields.She manually deleted all the previous patient's demographics before she could enter the current patient.The ekg of the patient whose demographics were found to have transmitted 2 times at approx 2.5 minutes apart, both coming from the same cart.This report was filed in our complaint handling system as complaint # (b)(4).

• 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: sarah oreilly ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 12643867
• MDR Text Key: 277773896
• Report Number: 2183461-2021-00009
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/16/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1