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IBP Module Invasive Blood Pressure ModuleRecalls & reported problems

Philips Medizin Systeme Böblingen GmbH · Invasive Blood Pressure Module · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838020917), received between Sep 8, 2025 and Sep 8, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Incorrect Measurement” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Incorrect Measurement1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 8, 2025Incorrect Measurement; Incorrect Measurement

    PHILIPS RECEIVED A COMPLAINT ON AN INVASIVE BLOOD PRESSURE MODULE. IT WAS REPORTED THE MONITOR DISPLAYED THE INCORRECT INTRACRANIAL PRESSURE (ICP); HOWEVER, IT WAS ALSO INDICATED THERE WAS NO HARM TO THE PATIENT. IT WAS ALSO STATED THERE WERE ADDITIONAL DRUGS ADMINISTERED BEYOND WHAT WAS EXPECTED FOR THE PROCEDURE, INCLUDING SEDATION, CURARE BOLUS, MANNITOL AND ADDITIONAL IV FLUID. THE PATIENT ALSO UNDERWENT MULTIPLE CT SCANS AND A CEREBRAL ULTRASOUND, WHICH CONFIRMED THE ICP VALUES HAD BEEN INCORRECT. THERE WERE NO CONSEQUENCES OR ACTUAL HARM TO THE PATIENT RELATED TO ALL THE DESCRIBED INTERVENTIONS AND THERE WAS NO CAUSE FOR THE REPORTED MALFUNCTION. BASED ON THE INFORMATION RECEIVED, IT APPEARS UNNECESSARY ADDITIONAL DRUGS WERE ADMINISTERED IN ADDITION TO EXTRA IMAGING. A MEDICATION ERROR, WHICH INCLUDES AN INCORRECT OR UNNECESSARY MEDICATION ADMINISTERED DUE TO AN ALLEGED DEVICE MALFUNCTION, WILL BE CONSIDERED A SERIOUS INJURY, AS MEDICAL INTERVENTION WAS PERFORMED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO BODY STRUCTURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22994929 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.