PageWriter PageWriter TC50 CardiographRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884838026568), received between Sep 9, 2020 and Mar 11, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Incorrect Measurement; Unable to Obtain Readings

  IT WAS REPORTED THAT ECG WAS NOT READING CORRECTLY. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575052 ↗
• MalfunctionSep 12, 2025No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE MX40 1.4 GHZ SMART HOPPING DEVICE INDICATING THAT, DURING EVALUATION AT BENCH REPAIR, THE DEVICE HAD NO SOUND. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23035625 ↗
• MalfunctionApr 30, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT, WHILE THE DEVICE IS ON, THE EARLY VUE VS30 VITALS MONITOR READS A FALSE SPO2 SATURATION RATE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935545 ↗
• MalfunctionOct 31, 2023Device Fell; Device Fell

  THE CUSTOMER REPORTED THAT THE DEVICE HAD FALLEN AND WAS VERY DAMAGED; THE REAR COVER IS DAMAGED, SOME SCREWS HAVE BEEN LOST, AND THE POWER SUPPLY CONNECTING HAS BEEN DAMAGED AS WELL. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME THE DEVICE FELL. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED. IT WAS UNKNOWN IF THE FALL WAS AN ACCIDENTLY DROP, OR IF THE DEVICE FELL DUE TO A MOUNTING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041500 ↗
• InjurySep 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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.

  Patient problems: Insufficient Information

  MAUDE report 17739431 ↗
• MalfunctionDec 27, 2022Fire; Fire

  PHILIPS RECEIVED A COMPLAINT ON THE PAGEWRITER TC50 CARDIOGRAPH INDICATING THAT THE DEVICE BATTERY CAUGHT FIRE DAMAGING THE UNIT. THE DEVICE WAS NOT IN CLINICAL USAGE AT THE TIME OF THE EVENT AND WAS ISOLATED IN A CHARGING ROOM. PHILIPS ENGINEERING CONFIRMED THAT THERE WAS NO REPORT OF A DEATH OR SERIOUS INJURY, NOR WAS THERE A REPORT OF ANY ADVERSE IMPACT TO ANY USER OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056738 ↗
• MalfunctionMay 14, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT AN "EXTERNAL FUSE BLOWS UP". THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824535 ↗
• MalfunctionMay 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE DEVICE SUFFERED A FALL. THE CUSTOMER REFUSED TO PROVIDE ANY FURTHER INFORMATION ON HOW THE DEVICE FELL. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777347 ↗
• MalfunctionSep 9, 2020Break

  THE CUSTOMER REPORTED THAT THE UNIT FELL AND BROKE. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO PATIENT OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10507034 ↗