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U.S. Department of Health and Human Services

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

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PHILIPS PHILIPS PAGEWRITER TC-70 CARDIOGRAPH MACHINES ECG MACHINES Back to Search Results
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.

 
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Brand NamePHILIPS PAGEWRITER TC-70 CARDIOGRAPH MACHINES
Type of DeviceECG MACHINES
Manufacturer (Section D)
PHILIPS
MDR Report Key7112058
MDR Text Key94850459
Report NumberMW5073928
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPAGE WRITER TC-70
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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