MAUDE Adverse Event Report: MIDMARK CORPORATION IQvitals Zone; System, Measurement, Blood-Pressure, Non-Invasive

Model Number	1-200-0350, 1-200-0330
Medical Device Problem Codes	Incorrect Measurement (1383); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction

• Brand Name: IQvitals Zone
• Common Device Name: System, Measurement, Blood-Pressure, Non-Invasive
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45830
• Manufacturer (Section G): Midmark Corporation; 60 vista drive; versailles OH 45830
• Manufacturer Contact: kort fledderjohann ; 60 vista drive; versailles, OH 45830
• MDR Report Key: 25762025
• Report Number: 1523530-2026-00005
• Device Sequence Number: 9715165
• Product Code: DXN
• UDI-Device Identifier: 00841709105807
• UDI-Public: 00841709105807
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K161909
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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
• Operator of Device: Health Professional
• Device Model Number: 1-200-0350, 1-200-0330
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 09/28/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown