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

Model Number QS6-MTTC1

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Abrasion (1689)

Event Date 08/22/2023

Event Type  malfunction  

Event Description

The customer reported that during the use of the qstress device in conjunction with a treadmill, after the device progressed the test/treadmill from stage 1 to stage 2, the patient requested the caregiver to stop the treadmill.Of note, this patient was reported to have a "phobia" of treadmills due to the patient falling from a treadmill at a previous undisclosed time.When the caregiver attempted to stop the test/treadmill via the qstress stop button, there was no response, the patient then fell sustaining a minor abrasion on her left hip.Upon the arrival of a second caregiver, the second caregiver pressed the estop button on the treadmill to stop the treadmill.The patient was assessed at the time of the event as well as at a later time by the patient's personal healthcare provider.No medical intervention was required at either assessment.This incident was captured under hillrom complaint ref # (b)(4).

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 device ifu states "when using a treadmill and an emergency occurs, depress the emergency stop button mounted on the handrail to stop the treadmill immediately." the inspection of the device by a baxer technician noted that the device's usb cable connecting the device's monitor to the cpu, which allows for the functionality of the device was "barely plugged in, causing the touch screen not to function.The technician reinserted the cable and the device worked as designed.An abrasion is a wound that is no deeper than the epidermis and is less severe than a laceration, and bleeding if present is minimal.Mild abrasions do not scar or bleed and typically do not require medical intervention to preclude permanent impairment of a body structure or body function.In this event, the patient did not sustain permanent impairment of a body function or permanent damage to a body structure and did not require medical or surgical intervention for the "mild abrasion" to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes no serious injury occurred.Additionally, the inspection ruled out a device malfunction and noted that the issue was likely due to a loose cable as a result of the customer's recent manipulating cables when operating the printer.If the event were to recur, and the device failed to respond ultimately resulting in a patient falling from the treadmill, it is likely to result in serious injury.Hillrom is reporting this incident.

• Brand Name: QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML
• Type of Device: 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: 17783294
• MDR Text Key: 323862090
• Report Number: 2183461-2023-00021
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2023

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-MTTC1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1