MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	PATIENT INFORMATION CENTER IX
Medical Device Problem Codes	No Audible Alarm (1019); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote clinical specialist engineer (cse) contacted the customer informing them of the star application note.The customer responded, "all the pic machines are assigning regular-rate-aflutter as sinus." the cse sent snippets from rev.N instructions for use (ifu), pages 184, 186 demonstrating most atrial flutters have regular r-r intervals, so they cannot be detected by the atrial fibrillation algorithm.186 rhythm status messages, sinus rhythm: a dominant rhythm of beats labeled as n or s preceded by p-waves.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
The customer reported that rhythm analysis is incorrect and the unit did not detect a-flutter.The device was in use on a patient at the time of the event, there was no adverse event reported.
Additional Manufacturer Narrative
Analysis was performed by a remote clinical specialist engineer (cse) which included informing the customer of the star application note and explaining to them the monitor does not alarm for a-flutter.The customer responded, "all the pic machines are assigning regular-rate-aflutter as sinus." the cse sent snippets from document number 453564830481 rev.A.00.00 instructions for use (ifu), page 184, chapter "atrial fibrillation alarm" which states "since most atrial flutters have regular r-r intervals, they cannot be detected by the atrial fibrillation algorithm".Page 186 chapter "rhythm status messages", table determines definition of sinus rhythm: (note: the label b or e indicates basic (b) or enhanced (e) arrhythmia capability.) rhythm status | message description | b or e.Sinus rhythm | a dominant rhythm of beats labeled as n or s preceded by p-waves.| b, e.The complaint was escalated for a technical complaint investigation for further review by an internal product support engineer (pse).The results confirmed the cse's writeup assessment is correct, the philips unit does not detect a-flutter and no alarm for a-flutter is possible.For available alarms, please refer to 453564830481 rev.A.00.00 instructions for use (ifu), pages 178 to 180, chapter ecg and arrhythmia alarms overview.Based on the information available in the case and provided by the cse and pse, the customer's alleged malfunction cannot be confirmed.The unit operated as design and is not designed to detect aflutter.The alleged malfunction was not confirmed.If additional information is received, the complaint file will be reopened for further investigation.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• 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: 24132904
• Report Number: 9610816-2026-100118
• Device Sequence Number: 10344299
• Product Code: MHX
• UDI-Device Identifier: 00884838104594
• UDI-Public: (01)00884838104594(10)4.0.1.0
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: PATIENT INFORMATION CENTER IX
• Device Catalogue Number: 866389
• Device Lot Number: 4.0.1.0
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/18/2026
• 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