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	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the treadmill emergency stop button was not functioning properly on the philips st80i stress test system.It is unknown if the device was in use on a patient at the time of the reported issue.No death or patient / user injury or harm was reported.
Event or Problem Description
The customer reported that the treadmill emergency stop button was not functioning properly on the philips st80i stress test system.It is unknown if the device was in use on a patient at the time of the reported issue.No death or patient / user injury or harm was reported.A philips remote service engineer (rse) spoke to the biomed at the customer site.During the testing it was confirmed that the cause for the reported issue was a failed emergency stop button.The biomed ordered and was provided with a replacement emergency stop assembly to repair the device and to resolve the issue.The device failed to work as intended.This issue was caused by a malfunction of the device and was resolved by the customer replacing the emergency stop assembly.It has been concluded that no further action is required.The device remains at the customer site.

• 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16415707
• Report Number: 1218950-2023-00100
• Device Sequence Number: 12107173
• Product Code: DQK
• UDI-Device Identifier: 00884838094840
• UDI-Public: 00884838094840
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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

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: 02/15/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 03/20/2023
• Date Device Manufactured: 03/13/2014
• 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