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
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 ↗
Other AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL devices
- LABSYSTEM™ PRO M00420020220Boston Scientific Corporation · AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL16 reports
- LABSYSTEM™ PRO M00420020210Boston Scientific Corporation · AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL4 reports
- LABSYSTEM™ PRO M00420020230Boston Scientific Corporation · AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL3 reports
- IDS WITH INTERGRATED MIB 7489375Draeger Medical Systems, Inc. · Amplifier And Signal Conditioner, Transducer Signal3 deaths3 reports
- LABSYSTEM™ PRO M0042002022R0Boston Scientific Corporation · AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL3 reports
- LABSYSTEM™ PRO M0042001267R0Boston Scientific Corporation · AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL2 reports
- LABSYSTEM™ PRO M00420020240Boston Scientific Corporation · AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL1 report
- LABSYSTEM™ PRO M0042002021R0Boston Scientific Corporation · AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.