MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue Patient Monitor MX550

Model Number	IntelliVue Patient Monitor MX550
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a red desat alarm was not generated at the bedside or central station when the patient's spo2 was in the 30's.The clinical specialist reviewed the clinical audit log, revealing spo2 desat alarms were generated and acknowledged.The staff reported no harm to the patient; however, good faith efforts were performed for clarification.
Additional Manufacturer Narrative
A good faith effort attempt conducted to get confirmation if there was a delay in treatment was unsuccessful.Analysis was performed by remote and onsite service personnel, which included review of the clinical audit trail/log files, alarm event review, customer interview, consultation with clinical support, functional alarm testing at the bedside monitor and central station, and efforts to reproduce the reported issue.The results of the analysis showed that the reported spo2 desaturation alarm was generated by the system on (b)(6) 2026 at 13:55:20, was subsequently acknowledged and re-alarmed, and remained active until the event ended at 13:58:45.Functional testing confirmed that alarm annunciation and acknowledgement operated as designed at both the bedside monitor and central station.No device errors, hardware failures, software malfunctions, or abnormal system behavior were identified, and the reported issue could not be reproduced.Based on the results of the analysis, the product was confirmed to be operating per specifications, and the reported problem was determined to be unconfirmed, as system records verified that the spo2 alarm was generated, displayed, and processed as designed during the reported event timeframe.No device malfunction was identified.The issue was resolved by reviewing the clinical audit trail, verifying alarm operation through functional testing, and communicating the investigation findings to the customer.No repair, adjustment, software update, or component replacement was required.A review of the available service history for this device did not identify recurring reports of the same alarm functionality issue following this event, and there was no evidence from the investigation to indicate an ongoing product performance problem.The device was found to meet specifications and was returned to service.

• Brand Name: IntelliVue Patient Monitor MX550
• Common Device Name: IntelliVue Patient Monitor MX550
• 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 ; +49(703)14632031
• MDR Report Key: 50815897
• Report Number: 9610816-2026-101939
• Device Sequence Number: 13293777
• Product Code: MHX
• UDI-Device Identifier: 00884838038783
• UDI-Public: (01)00884838038783
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K131872
• 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
• Report Date (Section B): 09/18/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: IntelliVue Patient Monitor MX550
• Device Catalogue Number: 866066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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: Life Threatening
• Patient Sex: Unknown