MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue MX400 Patient Monitor; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	IntelliVue Patient Monitor MX400
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a battery fault alarm occurred in the recovery room following a hysteroscopic resection.The nurse observed a "battery fault" alarm, and the battery status indicator flashed red.Upon inspection by the hospital's equipment engineers, it was noted that the monitor's battery status was 0% and battery current was 0ma, and the battery would not charge properly.There was no actual patient harm reported in the complaint; therefore, good faith efforts are being performed.
Additional Manufacturer Narrative
E1 reporter phone #: (b)(6) hospital engineers investigated and performed battery swap testing.Their testing indicated that the suspect battery would not charge when installed in a different monitor.However, a known-good battery would charge normally when installed in the suspect monitor.Based on these findings, the hospital concluded that the monitor charging circuitry was functioning properly and that the issue was associated with the battery itself.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.

• Brand Name: IntelliVue MX400 Patient Monitor
• 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 ; +49(703)14632031
• MDR Report Key: 50837866
• Report Number: 9610816-2026-101960
• Device Sequence Number: 15965318
• Product Code: MHX
• UDI-Device Identifier: 00884838038752
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130849
• 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
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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 MX400
• Device Catalogue Number: 866060
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 01/17/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female