MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS ST80I STRESS TEST SYSTEM

Model Number	860343
Medical Device Problem Codes	Unintended System Motion (1430); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that red button is not stopping/ pim not communicating with computer.It unknown if the device was in use at the time of the event, no reported patent impact.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that that red button is not stopping/ pim not communicating with computer.It unknown if the device was in use at the time of the event, no reported patent impact.

• Brand Name: PHILIPS ST80I STRESS TEST SYSTEM
• Common Device Name: PHILIPS ST80I STRESS TEST SYSTEM
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14758728
• Report Number: 1218950-2022-00503
• Device Sequence Number: 6106704
• Product Code: DQK
• UDI-Device Identifier: 00884838094840
• UDI-Public: 00884838094840
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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