MAUDE Adverse Event Report: WELCH ALLYN, INC. BUR280 STD WITH AM12; ELECTROCARDIOGRAPH

Model Number BUR280-C1X

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

Initial testing and investigation by hillrom technician found that the eli 280 had incorrect demographic information on newly performed ekg.The customer reported that ecg studies are periodically being sent from the eli 280 device that has incorrect demographic information to the facility's epiphany ekg management system.The customer also reported that the demographic information is being changed on an existing study to demographic information of a newly performed ekg.There was no report of injury associated with this event.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.Although there was no report of injury associated with this event, if the event were to recur, it could result in serious injury if the demographics of an ecg were changed causing mismatching of results to an improper patient.Due to the potential for serious injury, this event is determined to be reportable.The investigation is ongoing, however if any additional relevant information such as corrective actions are identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

The customer reported studied that are periodically sent from the eli280 ecg device have the incorrect demographic information.The customer noted that it appeared that demographic information is being changed on an existing study on the eli280 and is sent outbound with the same study id, changing the information in the customer's epiphany system.The demographic information is being updated to information of a newly performed ekg.The device was located at the account at the time of the reported event.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

Testing and investigation by hillrom technician found that the eli 280 had incorrect demographic information on newly performed ecg.The customer reported that ecg studies are periodically being sent from the eli 280 device that has incorrect demographic information to the facility's epiphany ecg management system.The customer also reported that the demographic information is being changed on an existing study to demographic information of a newly performed ecg.There was no report of injury associated with this event.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.Following the receipt of this complaint , welch allyn has identified that a software fault exists on the eli 280 software which may lead to one of the following transmission errors: 1) a specific sequence of operator inputs can lead to the transmission of a different ecg record than the record intended to be transmitted into an electronic medical record(emr) system.2) a specific sequence of operator inputs could cause patient exam demographics to be incorrectly attached to the waveform of another patient and be printed or transmitted into an emr system.Engineering investigation of the anomalies confirmed that, an eli280 operator, through a sequence of operator inputs, could transmit incorrect patient ecg waveform exam information to an emr system.Additionally, a specific sequence of operator inputs could cause patient exam demographics to be incorrectly attached to the waveform of another patient and be printed or transmitted to an emr system.Both issues have the same potential root cause in the eli280 electrocardiograph software version 2.1.0 through 2.3.0 but are caused by different operator sequence workflows.Therefore, hillrom is recommending a medical device correction (software upgrade) due to the potential quality issue leading to delay of critical care or incorrect treatment leading to inadequate perfusion of a critical organ.Recommended field action plan: an initial communication will be sent notifying customers of the issue, providing clinical mitigations and advising them not to utilize specific workflows.The customer will be asked to request for software update link via email to a designated field action email address.The software download link will be provided, via email, to the end user.End user will be required to follow instructions for installing software upgrade to their devices and return a response form indicating their devices are upgraded or provide a printed configuration sheet showing the software version is installed.Hillrom can confirm there have been no reports of any harm during the estimated 202 million patient experiences, however hillrom is conducting this field corrective action to correct the software and therefore prevent the above potential scenarios from occurring.Due to the potential for serious injury, this event is determined to be reportable.Hillrom notified the fda on the 8/12/2021 with report of corrections and removal number 2183461-08/12/2021-002-c.The internal reference number of this field action is fa-2021-07-001-mke-005.

Event Description

The customer reported studied that are periodically sent from the eli280 ecg device have the incorrect demographic information.The customer noted that it appeared that demographic information is being changed on an existing study on the eli280 and is sent outbound with the same study id, changing the information in the customer's epiphany system.The demographic information is being updated to information of a newly performed ecg.The device was located at the account at the time of the reported event.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: BUR280 STD WITH AM12
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): WELCH ALLYN, INC.; 7865 n 86th street; milwaukee WI 53224
• MDR Report Key: 12146717
• MDR Text Key: 261949149
• Report Number: 2183461-2021-00007
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00812345026252
• UDI-Public: 812345026252
• Combination Product (y/n): N
• PMA/PMN Number: K122073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

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 Operator: Health Professional
• Device Model Number: BUR280-C1X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2183461-08/12/2021-002-C
• Patient Sequence Number: 1