MAUDE Adverse Event Report: MORTARA INSTRUMENT WADCS ECG WAM AHA BAN DICOM; ELECTROCARDIOGRAPH

Model Number CC-RXX-WADX

Device Problem Patient Data Problem (3197)

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

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

The welch allyn diagnostic cardiology suite is a prescription device intended for use by physicians, other licensed health care practitioners, and trained personnel who are acting on the orders of a physician.Welch allyn diagnostic cardiology suite is intended for use in medical clinics, physician offices and hospital settings to acquire, analyze, display, transmit and print certain physiological signals identified below and provide the data for consideration by a physician.Welch allyn diagnostic cardiology suite utilizes a software platform to support 12-lead diagnostic resting ecg and diagnostic spirometry applications and is designed to operate within the inherent capabilities of an off-the-shelf laptop or pc windows operating system.Welch allyn diagnostic cardiology suite also provides functions related to patient data management including communication with electronic medical records systems.Welch allyn diagnostic cardiology suite resting ecgs are intended to be taken with the patient in the supine position and offer veritas¿ resting ecg algorithm to generate measurements and advisory statements for review and interpretation by the physician.Welch allyn diagnostic cardiology suite is not intended to be used as a physiological vital signs monitor, not intended to be used in a mobile medical environment (e.G.Ambulance, helicopter), in magnetic resonance (mr) environments, in operating theaters, nor in conjunction with high frequency surgical equipment.Indications for welch allyn diagnostic cardiology suite resting ecg range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department.Welch allyn diagnostic cardiology suite ecg is indicated for patients of all ages.It is noted that two ad-hoc (no system order) ecgs were performed at the exact same time of day (hour, minute, second), at different facilities within the same health care entity.An ad-hoc ecg, transmitted using elilink, is assigned a study instance unique identifier (uid).The uid is composed of a base unique to the product, the date and time (hour, minute, second) of the acquired ecg, and a sequence number.In the event two ecgs are completed at the same time (e.G.Patient 1 and patient 2), and assigned the same uid when transmitted using eli-link, the receiving facility¿s communication system (fuji/vidistar pacs system) would recognize the ecg¿s as only one patient.The first record from patient 1 would be associated to the correct patient (patient 1); however, the second record (patient 2 containing the same uid as the first record ) would be associated with the incorrect patient (patient 1) since it is assigned the same uid.This would result in the waveform of the second record (patient 2) to be paired and mistakenly filed by the user in patient 1 record/chart with patient 1 demographics.No record would be immediately available for patient 2 as both waveforms would be associated with patient 1.Although this reported event did not result in patient injury, if this event were to recur, this collision of data could possibly result in the delay of care for a patient experiencing a critical cardiac event (stemi).Evaluation, recognition, and treatment of patients with potentially life-threatening cardiac events is crucial.Standard practices outlining time-sensitive medical intervention involving such events is common (e.G door to balloon time).A delay in care due to an ecg result being assigned to the incorrect patient resulting in delay in recognition and treatment could be life-threatening.Therefore, the reported event is considered reportable.No further information is available on the repair at this time.If any additional relevant information is identified following completion of the repair, the additional relevant information will be submitted in a supplemental report.

Event Description

Hillroom received a report from the customer stating it was reported that the ecg waveform following transmission did not match the patient identification.The ecg devices were located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The welch allyn diagnostic cardiology suite is a prescription device intended for use by physicians, other licensed health care practitioners, and trained personnel who are acting on the orders of a physician.Welch allyn diagnostic cardiology suite is intended for use in medical clinics, physician offices and hospital settings to acquire, analyze, display, transmit and print certain physiological signals identified below and provide the data for consideration by a physician.Welch allyn diagnostic cardiology suite utilizes a software platform to support 12-lead diagnostic resting ecg and diagnostic spirometry applications and is designed to operate within the inherent capabilities of an off-the-shelf laptop or pc windows operating system.Welch allyn diagnostic cardiology suite also provides functions related to patient data management including communication with electronic medical records systems.Welch allyn diagnostic cardiology suite resting ecgs are intended to be taken with the patient in the supine position and offer veritas¿ resting ecg algorithm to generate measurements and advisory statements for review and interpretation by the physician.Welch allyn diagnostic cardiology suite is not intended to be used as a physiological vital signs monitor, not intended to be used in a mobile medical environment (e.G.Ambulance, helicopter), in magnetic resonance (mr) environments, in operating theaters, nor in conjunction with high frequency surgical equipment.Indications for welch allyn diagnostic cardiology suite resting ecg range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department.Welch allyn diagnostic cardiology suite ecg is indicated for patients of all ages.It is noted that two ad-hoc (no system order) ecgs were performed at the exact same time of day (hour, minute, second), at different facilities within the same health care entity.An ad-hoc ecg, transmitted using elilink, is assigned a study instance unique identifier (uid).The uid is composed of 1) a base unique to the product, 2) the date and time (hour, minute, second) of the acquired ecg, and 3) a sequence number.In the event two ecgs are completed at the same time (e.G.Patient 1 and patient 2), and assigned the same uid when transmitted using eli-link, the receiving facility¿s communication system (fuji/vidistar pacs system) would recognize the ecg¿s as only one patient.The first record from patient 1 would be associated to the correct patient (patient 1); however, the second record (patient 2 containing the same uid as the first record ) would be associated with the incorrect patient (patient 1) since it is assigned the same uid.This would result in the waveform of the second record (patient 2) to be paired and mistakenly filed by the user in patient 1 record/chart with patient 1 demographics.No record would be immediately available for patient 2 as both waveforms would be associated with patient 1.Although this reported event did not result in patient injury, if this event were to recur, this collision of data could possibly result in the delay of care for a patient experiencing a critical cardiac event (stemi).Evaluation, recognition, and treatment of patients with potentially life-threatening cardiac events is crucial.Standard practices outlining time-sensitive medical intervention involving such events is common (e.G door to balloon time).A delay in care due to an ecg result being assigned to the incorrect patient resulting in delay in recognition and treatment could be life-threatening.The investigation found that the uid for each ad-hoc exam is based on the time the exam was completed.If two exams are taken at the exact same time (within the same second) this could potentially lead to an instance where the uid for two exams are the same.The review of the risk assessment found that since the dcs software is used in a very limited number of acute care facilities (it is primarily used in primary care, non-acute settings) this could lead to the potentially hazardous situation - potential delay in critical care which is a critical severity.Based on post-market complaint data this specific issue has only been reported once making the likelihood or recurrence remote.The clinical team agrees the probability of leading to harm is unlikely, as following good clinical practice would include assessment of the patient's clinical presentation and other diagnostic tests would be considered when prescribing treatment.The patient would also most likely be presenting with additional symptoms that would also be considered by the clinical staff.The single complaint generated for this issue indicates no allegations of harm.Therefore, the probability of harm is deemed improbable and medium risk.Due to the above risk assessment, hillrom does not consider this a reportable malfunction at this time.

Event Description

Hillrom received a report from the customer stating it was reported that the ecg waveform following transmission did not match the patient identification.The ecg devices were located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: WADCS ECG WAM AHA BAN DICOM
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: sarah o'reilly ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 12377497
• MDR Text Key: 268472150
• Report Number: 2183461-2021-00008
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00817655022598
• UDI-Public: 817655022598
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191013
• 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,Followup
• Report Date: 12/15/2021

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 Model Number: CC-RXX-WADX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 12/20/2021
• 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