MAUDE Adverse Event Report: MORTARA INSTRUMENT QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC; ELECTROCARDIOGRAPH

Model Number	QS6-ATTD1
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The q-stress device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing.The device is intended for use in adult, adolescent, and children patient populations.The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician.The device may interface with equipment 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.Log files were reviewed and it was determined that the reported problem was due a software issue.Technical services walked the customer through how to reconcile the exam data to the correct patient.Based on this information, no further actions are required at this time.Although there was no injury reported as a result of this event, if patient data were to be mis matched on the system or an exam, it could lead to serious injury or death.Therefore, hillrom is reporting this malfunction.
Event or Problem Description
The customer reported that study patient information changed at the beginning of the study.There was no adverse event reported.This incident has been captured under hillrom complaint #(b)(4).

• Brand Name: QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC
• 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: 19921347
• Report Number: 2183461-2024-00032
• Device Sequence Number: 15482082
• Product Code: DPS
• UDI-Device Identifier: 00812345027563
• UDI-Public: 812345027563
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/06/2024

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: QS6-ATTD1
• 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: 07/17/2024
• Initial Report FDA Received Date: 08/06/2024
• 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