MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX

Model Number	866389
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1218950-2024-000861, this complaint is a supplemental to (mfr report # 1218950-2024-000861) due to incorrect registration number used.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported that the ibp alarms did not sound at the patient information center ix.The device was in use on a patient.No patient or user harm was reported.
Additional Manufacturer Narrative
A good faith effort conducted confirmed the allegation was against ibp (invasive blood pressure) / abp (arterial blood pressure) and not nibp (non invasive blood pressure).A philips field service engineer (fse) was onsite for an unrelated issue.The customer recently changed the monitoring software revision of 2 units (mx800 rev l to mx750 rev p and pic a.16 to pic 4).Now they see bp without a pulse inop, which in theory sounds, but the field service engineer (fse) has witnessed that it does not sound; he wants not know what is the correct operation? the clinical configuration, device status reports and clinical audit logs were obtained by the fse.The complaint was escalated for technical investigation to the responsible product support engineer (pse) to verify if the 'bp no pulse' inop had appeared and possibly sounded on (b)(6) 2024 between 9 and 12am.The pse stated within the data provided, there was no entry in the audit log for the alleged timeframe.In the audit log are only entries for invasive blood pressure (ibp).The pse found multiple entries for 'bp without a pulse' inop's other then in the alleged date and time.The 'bp no pulse' inop's toggling very quickly between the state on and off.The explanation that the inop is very quickly toggling between the on/off state is very likely preventing the inop sound to occur.The pse stated further that assuming the allegation from the field service engineer (fse) is ¿no pulse inop did not sound¿´ instead of ¿bp without a pulse, which in theory sounds, but witnessed it does not sound; what is the correct operation¿, then there are relevant entries in the audit log for (b)(6) 2024.The pse stated that the alarm sound could be missing, since the alarm generated/terminated is toggling so quickly.From the pse experience with consumables, the quick toggling could be related to a hardware defect of the sensor cable or adapter cable (intermittent contact).This might be a possible root cause as the field service engineer (fse) stated in the customer feedback that he understands that he at a first instance must change the consumable to new ones.Based on the information available and the testing conducted a final root cause was not established.The reported problem was confirmed as witnessed by the fse.Information was provided to the customer.The device remains is use.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: PATIENT INFORMATION CENTER IX
• 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: 21313281
• Report Number: 9610816-2025-000102
• Device Sequence Number: 18184967
• Product Code: MHX
• UDI-Device Identifier: 00884838104594
• UDI-Public: (01)00884838104594(10)4.0.1.0
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K211900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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
• Patient Sex: Unknown