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

Model Number 860343

Device Problems Unintended System Motion (1430); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event 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
• Type of Device: 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
• MDR Text Key: 294610065
• Report Number: 1218950-2022-00503
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00884838094840
• UDI-Public: 00884838094840
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• 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
• Device Operator: Health Professional
• Device Model Number: 860343
• Device Catalogue Number: 860343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1