MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX700; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	INTELLIVUE PATIENT MONITOR MX700
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the nurses did not hear an alarm generated for a desaturation event.The staff discovered the patient, an infant, that was blue in color and initiated resuscitation.It was noted there was no alarm prior to the patient being found but that an alarm was generated after resuscitation began.
Additional Manufacturer Narrative
A philips technical consultant (tc) was dispatched to the customer site.The event took place on (b)(6) 2025 at 10:51 in the nicu bed a601.The biomed instructed the end user to move the patient to a different monitor once the patient was stabilized.The tc was unable to reproduce the reported issue.Multiple test alarms were generated, and the audible alarm sounded correctly on the bedside monitor, surveillance central, and overview central; the speakers were operating properly.Following validation of the monitor, the tc released the device to customer use.The tc assisted the customer with obtaining the clinical audit trail from their in-house investigation into the issue.The customer declined further assistance from philips.The clinical audit logs were reviewed by the tc and a philips product support engineer (pse).The first desat was acknowledged at10:36:20 the bedside.This was just a few seconds after annunciation.The monitor reminded the users at 10:39, and again at 10:42 (3 min intervals) that the patient was still in the desat condition.The patient left desat at 10:42:46 and transitioned to spo2 low (yellow alarm) until 10:43:13 when they left that state with a normal spo2 value.Spo2 alarms were generated; however, the user had silenced/acknowledged the alarm.The reported problem was not confirmed.Information was provided to the customer.

• Brand Name: INTELLIVUE PATIENT MONITOR MX700
• 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: 23547035
• Report Number: 9610816-2025-001061
• Device Sequence Number: 9449089
• Product Code: MHX
• UDI-Device Identifier: 00884838029088
• UDI-Public: (01)00884838029088
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K150310
• 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): 11/13/2025

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: INTELLIVUE PATIENT MONITOR MX700
• Device Catalogue Number: 865241
• 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: 10/20/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2018
• 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: Required Intervention
• Patient Sex: Unknown