PageWriter PageWriter TC70 CardiographRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00884838026582), received between Mar 12, 2019 and Aug 3, 2026 — classified as 1 death, 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50111968 ↗
• MalfunctionJul 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25860502 ↗
• MalfunctionJul 10, 2026Sparking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785612 ↗
• MalfunctionApr 11, 2026Incorrect Measurement; High Readings

  THE CUSTOMER REPORTED THAT THE TC70 MONITOR WAS DISPLAYING ERRONEOUS INFORMATION, SPECIFICALLY A PERSISTENT ATRIAL FIBRILLATION (A-FIB) READING ON PATIENTS WHO WERE SUBSEQUENTLY CLINICALLY ASSESSED AND CONFIRMED NOT TO HAVE A-FIB. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24850630 ↗
• MalfunctionJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A COMPLAINT ON THE PAGEWRITER TC70 CARDIOGRAPH INDICATING THAT THE WHEEL BROKE OFF THE EKG CART WHILE MOVING IT. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080459 ↗
• DeathJun 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE TC70 INTERPRETED AN ECG INCORRECTLY AND MISSED PROLONGED QT INTERVAL AS THE INTERPRETATION. IT WAS REPORTED THAT THE PATIENT PASSED AWAY LATER THAT DAY AFTER BEING RELEASED FROM THE HOSPITAL.

  Patient problems: Cardiac Arrest; Insufficient Information

  MAUDE report 14846409 ↗
• MalfunctionApr 18, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE DEVICE'S CART HAS A BROKEN CASTER. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135799 ↗
• MalfunctionDec 6, 2021Defective Component; Defective Component

  THE CUSTOMER REPORTED THE BOTTOM BRACKET THAT HOLD THE WHEELS TO THE TROLLEY CHASSIS IS BROKEN AND THE SHIPPING BOX WAS NOT DAMAGED. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12944226 ↗
• MalfunctionAug 13, 2021Defective Component; Defective Component

  CUSTOMER REPORTED THAT THE METAL FRAME HOLDING THE WHEEL CASTERS SNAPPED OFF AT ONE CORNER ON THEIR NEW TC70 CART. THERE WAS NO PATIENT HARM OR INJURY REPORTED. 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 12317809 ↗
• MalfunctionJun 4, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE FRONT CASTER ON THE TROLLEY IS BROKEN. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION ON THE DAMAGE. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939978 ↗
• MalfunctionFeb 24, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  CUSTOMER REPORTED UPON ARRIVAL, WHEN THEY LIFTED THE CART THE WHEELS FELL OFF. THERE WAS PHYSICAL DAMAGE NOTED UPON FURTHER INSPECTION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11373155 ↗
• MalfunctionSep 15, 2020Sparking

  THE CUSTOMER REPORTED THAT SPARKS APPEARED WHEN PLUGGING THE POWER CORD INTO THE WALL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10535779 ↗
• MalfunctionAug 25, 2020Fire; Material Rupture

  CUSTOMER REPORTED THE BATTERY EXPLODED AND THE UNIT CAUGHT ON FIRE. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10448594 ↗
• MalfunctionJun 19, 2020Break

  THE CUSTOMER REPORTED THE CASTER SNAPPED OFF THE CART UPON ARRIVAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10174179 ↗
• MalfunctionAug 7, 2019Computer Operating System Problem

  CUSTOMER REPORTED THEIR SYSTEM INTERMITTENTLY LOCKS UP. PATIENT INVOLVEMENT IS CURRENTLY UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8871414 ↗
• InjuryJun 22, 2019Connection Problem

  CUSTOMER REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE UNIT AND THE PIM. THIS CAUSED A DELAY IN TREATMENT DURING AN EMERGENCY SITUATION. THE CONNECTION ISSUE CAUSED A DELAY IN TREATMENT. CUSTOMER HAD TO USE A SECOND EKG UNIT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8725451 ↗
• InjuryJun 22, 2019Connection Problem

  CUSTOMER REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE UNIT AND THE PIM. THIS CAUSED A DELAY IN TREATMENT DURING AN EMERGENCY SITUATION. THE CONNECTION ISSUE CAUSED A DELAY IN TREATMENT. CUSTOMER HAD TO USE A SECOND EKG UNIT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8725450 ↗
• MalfunctionMar 12, 2019Image Display Error/Artifact

  THE CUSTOMER REPORTED THE DEVICE WAS FREEZING UP WITH WAVEFORMS. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8412464 ↗