PageWriter PageWriter TC30 CardiographRecalls & reported problems
Philips Medical Systems Hsg · PageWriter TC30 · Class 2
All models of PageWriter (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884838081123), received between Jun 17, 2020 and Feb 24, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Compatibility Problem” (1 report).
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
Device problems
- Compatibility Problem1
- Computer Operating System Problem1
- Data Problem1
- Device Emits Odor1
- Insufficient Device Problem Information1
- Patient Data Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT FOLLOWING A FALL, THE DEVICE HAD SEVERAL BROKEN PARTS. GOOD FAITH EFFORTS (GFE) HAVE BEEN MADE BY THE INVESTIGATOR TO OBTAIN ADDITIONAL INFORMATION REGARDING HOW THE DEVICE FELL WITHOUT A RESPONSE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THERE WAS NO REPORTED PATIENT IMPACT/INJURY.
Patient problems: No Patient Involvement
MAUDE report 11376362 ↗MalfunctionNov 6, 2020Device Emits Odor
CUSTOMER REPORTED A BURNING SMELL AND THE UNIT FAILED TO POWER ON. THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10805213 ↗MalfunctionJun 17, 2020Computer Operating System Problem; Compatibility Problem
CUSTOMER REPORTED THE UNIT SENDS DATA TO THE SERVER INCORRECTLY, CAUSING A MISMATCH BETWEEN TWO PATIENTS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10165102 ↗MalfunctionJun 17, 2020Data Problem
CUSTOMER REPORTED THE UNIT SENDS DATA TO THE SERVER INCORRECTLY, CAUSING A MISMATCH BETWEEN TWO PATIENTS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10164614 ↗MalfunctionJun 17, 2020Patient Data Problem
CUSTOMER REPORTED THE UNIT SENDS DATA TO THE SERVER INCORRECTLY, CAUSING A MISMATCH BETWEEN TWO PATIENTS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10163378 ↗
Other ELECTROCARDIOGRAPH devices
- ELI 380 ELI380-DCS11Mortara Instrument, Inc. · Electrocardiograph1 recall1 death70 reports
- Cardiac Workstation Cardiac Workstation 7000Philips Medizin Systeme Böblingen GmbH · Electrocardiograph2 recalls17 reports
- Q-Stress QSERV-6AA-XXXXBMortara Instrument, Inc. · Electrocardiograph2 recalls1 report
- Cardiac Workstation Cardiac Workstation 5000Philips Medizin Systeme Böblingen GmbH · Electrocardiograph2 recalls1 report
- MAC VU360GE Medical Systems Information Technologies, Inc. · Electrocardiograph2 recalls1 report
- XScribe Cardiopulmonary Kit 41000-030-60Mortara Instrument, Inc. · Electrocardiograph2 recalls0 reports
- Welch Allyn, Inc. 901049Welch Allyn, Inc. · ELECTROCARDIOGRAPH2 recalls0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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