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

Model Number	860343
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was assisted by a philips remote service engineer (rse).The rse provided the part number and ordered a replacement emergency stop button.The customer is taking responsibility to correct/repair the device.The customer was notified to contact philips if this does not address their device issue.
Event or Problem Description
Philips received a complaint on the oem trackmaster tmx428 treadmill 220v indicating that the emergency stop (e-stop) button was no longer working.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.The biomed engineer at the customer facility evaluated the device and determined that the e-stop button requires replacement.

• 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: 16556083
• Report Number: 1218950-2023-00128
• Device Sequence Number: 14179737
• Product Code: DQK
• UDI-Device Identifier: 00884838094840
• UDI-Public: 00884838094840
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/16/2023
• 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