MAUDE Adverse Event Report: MORTARA INSTRUMENT XS6 WAM TTL SYS AHA XML; ELECTROCARDIOGRAPH

Model Number	XSCRIBE-6AA-BXAAA
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has been contacted for further information on the reported event.Log files have been requested and will be analysed.Investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Event or Problem Description
The customer alleged that the xscribe patient exam was overwritten with the details of the patient who had the following test.There was no allegation of patient or caregiver injury, or death reported from this alleged incident.This report was filed in our complaint handling system as (b)(4).
Additional Manufacturer Narrative
The xscribe is a pc-based diagnostic tool intended to acquire, process, and store ecg data of patients undergoing stress exercise testing.The software records ecg, heart rate, and st data, and creates summary tables, trends, and a final report regarding a variety of cardiac data indices.The cardiac data provided by xscribe is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of the electrocardiographic data reflecting the patient's physiological condition during stress exercise testing.The 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 device may interface with equipment for pulmonary function testing and other devices, including a treadmill or ergometer for dynamic exercise evaluation, as well as non-invasive blood pressure equipment, functional arterial oxygen saturation (spo2) equipment, and computer communications equipment.The device is not intended to be used as a vital signs physiological monitor.Upon inspection, hillrom service technician found that the overwritten details of the patient could be replicated after multiple testing.Although the reported event did not result in a serious injury or death, the report of a patient demographics mismatch in ecg tests could lead to a misdiagnosis or mistreatment, if it were to recur.Therefore, hillrom considers this complaint reportable.
Event or Problem Description
The customer alleged that the xscribe patient exam was overwritten with the details of the patient who had the following test.There was no allegation of patient or caregiver injury, or death reported from this alleged incident.This report was filed in our complaint handling system as (b)(4).

• Brand Name: XS6 WAM TTL SYS AHA XML
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16589827
• Report Number: 2183461-2023-00007
• Device Sequence Number: 11248891
• Product Code: DPS
• UDI-Device Identifier: 00732094301489
• UDI-Public: 732094301489
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: XSCRIBE-6AA-BXAAA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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