MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS ST80I STRESS TEST SYSTEM

Model Number	860343
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the emergency stop button was not working on treadmill.The device was reported to be in use on a patient.No adverse event to the patient or user was reported.
Additional Manufacturer Narrative
The following functional tests were performed: a field service engineer (fse) went onsite to evaluate the device and found that the device had an intermittent issue with recognizing the emergency stop button when beeing pressed or enabled.The fse reseated the communication cable between the treadmill and stress test system.Furthermore the fse recalibrated the treadmill by implementing the micro sd card in the treadmill and running through software setup and calibration.Afterwards the fse confirmed that the "e stops" worked as expected both in service mode and stress test mode.Based on the information available and the testing conducted, the exact cause of the reported problem is unknown.The reported problem was confirmed.The communication cable was reseated.However, the exact cause for the reported issue could not be established.If additional information is received the complaint file will be reopened.
Event or Problem Description
It was reported that the emergency stop button was not working on treadmill.The device was reported to be in use on a patient.No adverse event to the patient or user was reported.

• Brand Name: PHILIPS ST80I STRESS TEST SYSTEM
• Common Device Name: PHILIPS ST80I 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: 20406151
• Report Number: 1218950-2024-00725
• Device Sequence Number: 3579380
• Product Code: DQK
• UDI-Device Identifier: 00884838094840
• UDI-Public: (01)00884838094840
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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
• Operator of Device: Health Professional
• Device Model Number: 860343
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• 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