MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX; CENTRALIZED PATIENT MONITOR

Model Number	PATIENT INFORMATION CENTER IX
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported the monitor did not generate an alarm when the patient went into cardiac arrest.This emergency department patient with a complex medical history that included drug and alcohol dependency along with mental illness, was found collapsed and partially responsive on the street following a drug relapse.At the time of admission, the urine toxicology screen revealed the presence of cocaine and benzodiazepines.The patient was stabilized and admitted at 4:00am.At 4:45am, the patient was discovered collapsed and unresponsive in the emergency bay and found to be in cardiac arrest.The event was not monitored as she had become disconnected from ecg, which is consistent with earlier attempts to remove ecg leads due to confusion and agitation.The disconnection of the leads was not noticed by staff as they were attending another patient emergently at the same time.After cardiac arrest was diagnosed, the patient was resuscitated with a return to spontaneous circulation but remained profoundly unconscious.The cardiac arrest resulted in an irreversible hypoxic brain injury and the patient did not regain neurological function.After nine days of observation, family consented to withdrawal of life support and the patient subsequently passed away.The cause of death was listed as 'combined drug toxicity (cocaine and benzodiazepines).The customer remained concerned with the configuration of the monitor in that a technical inop alarm that occurs due to ecg leads off can be acknowledged and not re-alarm.
Additional Manufacturer Narrative
E1 reporter phone #: (b)(6).Analysis was performed by onsite personnel.The clinical application specialist (cas) advised that due to the time elapsed since the event (almost 4 months), it is no longer possible to view audit logs for this patient as the 90 days has been exceeded.The cas reviewed the configuration from the mx800 monitors at the customer's site and confirmed the inop severity of ecg leads off is cyan (this is standard for most trusts) which means the alarm lamp blinks until the active inop is acknowledged, and will not make an audio alarm again, however the cyan banner will remain in the top left corner of the screen.In an email to the customer on april 11, 2025, the cas advised the customer of this finding, provided a summary of how the philips inop alarm works, and recommend changing this to a yellow alarm for roll out of the new monitors.The cas explained that this simply means that if an ¿ecg leads off¿ alarm is generated you will get the visual yellow flashing banner, lamp and sound - if the alarm is acknowledged the yellow banner will remain and the audio will re-alarm after 3 mins if ecg leads are still off.This should encourage more actionable responses to what the monitor is telling you.In a follow-up email on june 16, 2025, the cas responded to the customer confirming that the reconfiguration on the ed monitors was rolled out on any monitors in a&e that have been upgraded recently and phdu.Based on the results of the analysis, the product was confirmed to be operating per specifications and the cause of the reported problem was alarm configuration and use related issue due to alarm management.The device remains in use at the customer's site.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: CENTRALIZED PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 23623384
• Report Number: 1218950-2025-000695
• Device Sequence Number: 13006332
• Product Code: MHX
• UDI-Device Identifier: 00884838086715
• UDI-Public: (01)00884838086715(10)C.02.00
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163584
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: PATIENT INFORMATION CENTER IX
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2018
• 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: Death
• Patient Age: 43 YR
• Patient Sex: Female