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

Model Number	CC-RXX-WAXX
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further troubleshooting into the reported issue could not be performed.The customer was advised to call back when available to perform further troubleshooting.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.Although there was no patient harm reported in this case, if incorrect patient information with the correct patient id pulling from the emr were to recur, it could lead to misdiagnosis and/or mistreatment which could ultimately lead to patient harm, therefore, baxter considers this complaint reportable.
Event or Problem Description
The customer reported incorrect patient information with the correct patient id was pulling from the emr.There was no adverse event reported.

• Brand Name: WADCS ECG WAM AHA BAN
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 22769060
• Report Number: 2183461-2025-00009
• Device Sequence Number: 15892758
• Product Code: DPS
• UDI-Device Identifier: 00817655022604
• UDI-Public: 817655022604
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 08/11/2025

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-WAXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown