MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS STRESS; STRESS TEST SYSTEM

Model Number	ST80I STRESS TEST SYSTEM
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips technical consultant (tc) went to the customer' site.The tc confirmed the st80i software passes performance verification tests and the "stop treadmill" button works.Based on the information available and the testing conducted, the cause of the reported problem is unknown as the customer's issue was not replicated.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
The customer reported that they hit the emergency stop button; however, the treadmill kept going.The device was reported to be in use on a patient.No adverse event to the patient or user was reported.
Additional Manufacturer Narrative
Additional information was requested to confirm if the reported issue was the emergency stop button on the treadmill itself or the stop treadmill button on the software interface.The philips technical consultant (tc) confirmed that the treadmill shut off power with the ¿emergency stop button".The tc stated there was a discrepancy on whether the treadmill ¿emergency stop button¿ stops the motor or actually stops the belt.The treadmill manual states "emergency stop switch the emergency stop switch is a safety device for use in emergency situation to stop the treadmill.Caution: when the emergency stop button (esb) is engaged or pressed in the closed position, the treadmill's running belt will coast to a stop and maintain elevation.Emergency stop switch check note: verify proper operation of the stop switch assembly very month.With the belt moving at a relatively high speed, press the emergency stop switch.The treadmill's running belt will coast to a stop and maintain elevation.To release the emergency stop switch, turn the push button 1/4-turn in a clockwise direction to pull to release.The treadmill will return to 0.0% elevation.If the treadmill is used with a host device or for clinical testing, the operator shall be within a distance that provides easy access to the emergency stop switch.In the event the patient falls and the patient safety tether lanyard fails to disengage use the emergency stop button on the treadmill to stop the treadmill as this disengages the motor and allows the treadmill to freewheel to a stop." the device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: STRESS
• Common Device Name: STRESS TEST SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 22569522
• Report Number: 1218950-2025-000415
• Device Sequence Number: 3904694
• Product Code: DQK
• UDI-Device Identifier: 00884838094840
• UDI-Public: (01)00884838094840
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K121638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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
• Operator of Device: Health Professional
• Device Model Number: ST80I STRESS TEST SYSTEM
• Device Catalogue Number: 860343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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