MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problems Use of Incorrect Control/Treatment Settings (1126); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2022

Event Type  Death  

Event Description

The customer reported that the mp30 bedside monitor which was connected to the pic ix system was accidentally placed in comfort care profile between 11:53 and 12:07 on the (b)(6).2022 and he did not hear any alarm.The monitored patient was coding for 10 minutes prior the emergency care staff attended to the patient.The device was in use on a patient.There was a patient death reported.

Manufacturer Narrative

Reporter institution phone number (b)(6).Reporter phone number (b)(6).A follow up report will be submitted after philips obtains more information concerning this event.

Event Description

Philips received a complaint on the patient information center ix indicating that there was an adverse event after the hospital personnel mistakenly changed the confirmation of the bedside device to that of comfort care.The event occurred between 1153-1207 hrs, (b)(6) 2022.The patient had coded for an extended length of time and passed away.There was no hospital staff intervention during the time that the patient was coding.The customer reported that the mp30 bedside monitor which was connected to the pic ix system was accidentally placed in comfort care profile between 11:53 and 12:07 on the (b)(6) 2022 and he did not hear any alarm.The monitored patient was coding for 10 minutes prior the emergency care staff attended to the patient.A philips field service engineer went onsite to obtain audit logs from the pic ix.A philips product support engineer(pse) reviewed the audit trail logs and found that alarms were generated at 1153-1207 hrs, (b)(6) 2022 for bed label ed 07 and the alarms were acknowledged.Based on the information available and the testing conducted, the cause of the reported problem was that the user mistakenly put the bedside monitor into a comfort care configuration.The device functioned according to specification during the event.The monitor appears to have functioned as configured; however, the user chose the incorrect patient profile.There was no confirmation of an issue.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15665190
• MDR Text Key: 302320675
• Report Number: 1218950-2022-00931
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: (01)00884838093041(10)C.03.07
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 79 KG