MAUDE Adverse Event Report: PHILIPS PHILIPS PAGEWRITER TC-70 CARDIOGRAPH MACHINES; ECG MACHINES

Model Number PAGE WRITER TC-70

Device Problem Date/Time-Related Software Problem (2582)

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

Event Date 12/11/2017

Event Type  malfunction  

Event Description

Time stamps recorded on the philips 12 lead ecg carts can be inaccurate by one hour.The time associated with 12 lead ecgs seems to be affected by the daylights savings and a synchronization errors with a main server.Philips continues to deny previous knowledge of this issue and will not provide documentation to warn our clinicians about the time associated with a 12 lead recording fluctuating between standard time and daylight savings time.While at the same time philips states that they have a software patch that has been in the works for over a month, designed to address the issue.

• Brand Name: PHILIPS PAGEWRITER TC-70 CARDIOGRAPH MACHINES
• Type of Device: ECG MACHINES
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 7112058
• MDR Text Key: 94850459
• Report Number: MW5073928
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2017

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: PAGE WRITER TC-70
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1