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

Model Number 860343

Device Problems Self-Activation or Keying (1557); Patient Data Problem (3197)

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

Event Type  malfunction  

Manufacturer Narrative

Philips attempted to contact the customer but was unsuccessful.

Event Description

The customer reported that when saving a study, the system pulls up the demographic information of a completed patient randomly.It was stated that this has been an ongoing issue, however, details regarding past issues were not provided.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: 10554635
• MDR Text Key: 208301525
• Report Number: 1218950-2020-05515
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• 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: 08/25/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2017
• 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