MAUDE Adverse Event Report: MORTARA INSTRUMENT Q-STRESS; 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	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the qstress 6 had a number of issues with test reports, including the patient name switched inside the exam when used in observation mode, and was unable to use secondary patient id when using mwl order.There was no injury reported.This event has been captured under hillrom complaint # (b)(4).
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.The customer declined to return the device for inspection, therefore a root cause into the reported events cannot be performed.A questionable or inaccurate interpretation between the physician's analysis of the ecg report and the device algorithm evaluation is unlikely to cause a serious injury or death as it is recommended in the user manual that the ecg reading should be reviewed by a physician and used in conjunction with the patient¿s presentation and other relevant clinical information prior to determining the patient¿s diagnosis and treatment.Due to the reasons listed above, hillrom does not consider inaccurate readings to be a reportable malfunction.However, if patient data were to be mis matched on the system, it could lead to serious injury or death.Therefore, hillrom is reporting this malfunction.
Additional Manufacturer Narrative
This supplemental report is a correction to the previously submitted mdr.Following communication from the fda regarding incorrect/missing udi numbers, baxter reviewed the subject mdr and determined brand name, 510k, and udi corrections were required to this mdr in alignment with the gudid.
Event or Problem Description
The customer reported the qstress 6 had a number of issues with test reports, including the patient name switched inside the exam when used in observation mode, and was unable to use secondary patient id when using mwl order.There was no injury reported.This event has been captured under baxter complaint # (b)(4).

• Brand Name: Q-STRESS
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18038835
• Report Number: 2183461-2023-00024
• Device Sequence Number: 18025199
• Product Code: DPS
• UDI-Device Identifier: 00812345027563
• UDI-Public: (01)00812345027563
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K152944
• 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): 06/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: QS6-ATTD1
• Was Device Available for Evaluation?: No
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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