MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC50 CARDIOGRAPH

Model Number	860310
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer wants to be able to alias ecg interpretation statements at on the tc50, so that when the er or urgent care provider sees the ecg print out, they will see "st changes" instead of "st elevation" which activates a stemi protocol.The result is that a number of patients have been sent to the cath lab, with some actually making it to the table, for no reason.Patient had an unnecessary invasive cardiac procedure.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This is an enhancement request for the tc50 printout to read st elevation instead of st change for the printout.The device was confirmed to be operating per specifications and no failure was identified.If additional information is received the complaint file will be reopened.
Additional Manufacturer Narrative
There is no product malfunction.Device was confirmed to be operating per specifications and displayed the appropriate interpretation by the algorithm.Customer has an enhancement request for the automated interpretive statement on the top of the report printout to read st changes rather than st elevation because due to their hospital¿s workflow they must initiate a stemi protocol if st elevation is stated on the report.Physician guide states ¿while increasingly detailed and well developed, no automated analysis is completely reliable, and computerized ecg analysis should always be reviewed by a qualified physician.The interpreted ecg is a tool to assist the physician in making a clinical diagnosis in conjunction with the physician¿s knowledge of the patient, the results of the physical examination, and other findings.

• Brand Name: PAGEWRITER TC50 CARDIOGRAPH
• Common Device Name: PAGEWRITER TC50 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17739431
• Report Number: 1218950-2023-00645
• Device Sequence Number: 6059951
• Product Code: DPS
• UDI-Device Identifier: 00884838026568
• UDI-Public: 00884838026568
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 860310
• Device Catalogue Number: 860310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 09/25/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/24/2023; 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown