MAUDE Adverse Event Report: MORTARA INSTRUMENT CONTRACT EQ MM-HSCRIBE-DICOM MIDDLEWARE; ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM

Model Number	MM-HSCRIBE-DICOM
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection, the technician was unable to find any malfunction with the device.The cause of the reported issue was determined to be use error where the customer chose the wrong patient from the work-list.The system correctly presented a list of patients, and it appears the user selected the wrong patient from that list.The hscribe system is indicated for use in a clinical setting, by qualified medical professionals only, for patients requiring ambulatory (holter) monitoring of 24-48 hours.Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis.The analysis software package includes, among others, detection and reporting features appropriate to the indications below: evaluation of adult patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia.Evaluation of adult patients for st segment changes.Evaluation of adult patients with pacemakers.Reporting of time domain heart rate variability.Evaluation of infant patients limited to qrs detection only.The baxter service thoroughly inspected the device and was unable to duplicate the reported issue.The device functioned as designed.However, if the reported event of an incorrect patient information record were to recur, it would be likely to cause or contribute to death or serious injury, therefore baxter considers this event reportable.
Event or Problem Description
The customer reported that they had a patient appearing twice in hscribe with exactly the same name, nhs number, date of birth, and setup timestamp (same day, hour, minute, and second).However, when opening each record, the ecg traces were completely different and clearly correspond to two different patients.There was no adverse event reported.

• Brand Name: CONTRACT EQ MM-HSCRIBE-DICOM MIDDLEWARE
• Common Device Name: ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: mauricio ; 1069 state route 46 east; batesville, IN 47006
• MDR Report Key: 24338651
• Report Number: 2183461-2026-00001
• Device Sequence Number: 9781648
• Product Code: MLO
• UDI-Device Identifier: 00732094281330
• UDI-Public: (01)00732094281330
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 02/13/2026

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: MM-HSCRIBE-DICOM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/13/2026
• 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