MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INVASIVE BLOOD PRESSURE MODULE

Model Number	INVASIVE BLOOD PRESSURE MODULE
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A philips application and sales specialist worked with the customer.Per the customer, the sensor was changed during a surgery procedure following high icp value at the bedside (40-60 mmhg).After a successful procedure and a correct icp value (5mmhg), the patient was transferred to a transport monitor where the icp was incorrect (51 mmhg).A zero procedure was attempted, but did not successfully restore the icp value.The customer changed the ibp module and obtained correct icp value (5-10 mmhg).Based on the information available and the testing conducted, the cause of the reported problem was a faulty invasive blood pressure module.The reported problem was confirmed.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.E1: reporting institution phone #: (b)(6).
Event or Problem Description
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.

• Brand Name: INVASIVE BLOOD PRESSURE MODULE
• Common Device Name: INVASIVE BLOOD PRESSURE MODULE
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 22994929
• Report Number: 9610816-2025-000820
• Device Sequence Number: 8914441
• Product Code: MHX
• UDI-Device Identifier: 00884838020917
• UDI-Public: (01)00884838020917
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INVASIVE BLOOD PRESSURE MODULE
• Device Catalogue Number: M1006B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown