MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ST8OI STRESS TEST SYSTEM; PHILIPS ST8OI STRESS TEST SYSTEM

Model Number 860343

Device Problem Computer Operating System Problem (2898)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer reported the application freezes during exams.The device was in use on a patient.There was no patient harm or injury reported.

• Brand Name: ST8OI STRESS TEST SYSTEM
• Type of Device: PHILIPS ST8OI STRESS TEST SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 9238754
• MDR Text Key: 170283799
• Report Number: 1218950-2019-08163
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00884838030299
• UDI-Public: (01)00884838030299
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2018
• 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