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

Model Number	866389
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/18/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.E1: reporter institution phone number: (b)(6).
Event or Problem Description
It was reported a patient incident occurred, resulting in death.The user indicated the alarms for ventricular tachycardia and ventricular fibrillation were missing, which resulted in a delay in care.No other clinical information or medical intervention was provided.
Additional Manufacturer Narrative
A philips field specialist (fs) went onsite to evaluate the device and pull the logs to be further evaluated by a philips product support engineer (pse).The fs troubleshot the device and there were no issues present.The fs tested the device, and it passed performance verification testing (pvt) working to specification.The philips pse evaluated the logs provided by the customer and concluded the following.According to the information in the email and product incident malfunction report (pimr), the event was at ~11pm on the 18th oct.When looking to the audit logs (b)(4), it is clearly visible that there have been several red alarms coming from the mx40 (c1tele1) which have been announced at the central.Red asystole, red ventricular tachycardia, as well as red ventricular fibrillation/tachycardia alarms have been reported during the time of event but also much earlier.Alarms were silenced at central station; therefore, a user most likely was aware of the alarms.The device worked to specification.No further investigation or action is warranted at this time.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: PATIENT INFORMATION CENTER IX
• 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: 20698451
• Report Number: 1218950-2024-00809
• Device Sequence Number: 19778963
• Product Code: MHX
• UDI-Device Identifier: 00884838104594
• UDI-Public: (01)00884838104594(10)4.0.1.0
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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: 866389
• Device Catalogue Number: 866389
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/30/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 94 KG