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

Model Number 866389

Device Problem Defective Alarm (1014)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2024

Event Type  Death  

Manufacturer Narrative

E1: reporting address line 1: (b)(6).E1: reporting institution phone#: (b)(6).E1: reporter phone#: (b)(6).A follow up report will be submitted after philips obtains more information concerning this event.

Event Description

It was reported the customer called into philips requesting assistance in printing data from alarm review, for which the technician provided guidance.The customer then called back several days later to request assistance in finding data as they were unable to find the data required.The customer alleged there were no audible alarms at the time of the event for the patient being monitored for ecg, spo2, and non-invasive blood pressure (nibp).It was also indicated the patients in this care area are not admitted or discharged and they have one patient for an extended period of time.The customer requested evidence of an audible alarm.At the time of the call, the customer indicated the data retrieval was for a patient who had passed away, at which point the philips engineer made an onsite visit.The engineer found no information on the monitor or at the nursing station regarding the patient room under review.The monitor was removed from service by biomedical engineering to perform functional testing.Based on the information received, it appears the alleged failure to alarm may have caused or contributed to the reported event.The device was in use on a patient.There was a report of patient harm.

Event Description

The customer alleged there were no audible alarms at the patient information center ix at the time of the event for the patient being monitored for ecg, spo2, and non-invasive blood pressure (nibp).Additional information was reviewed.This information indicated the patient did not pass away and the customer was lodging a complaint that when they open or close the spo2 parameters, they may accidentally turn off the alert because they are next to each other in the menu.Based on this information, the customer was relaying a potential harm and not an actual harm to the patient.

Manufacturer Narrative

The provided information and log data were reviewed by a philips authorized distributor.After investigation it was confirmed that there was no patient impact/contribution to a death or other patient harm.Based on the information that is available, no product malfunction can be determined.In addition, the customer issue was that when you open or close the spo2 parameter, they may accidentally turn off the alert because it is next to each other in the menu.This will be considered an enhancement request.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19039508
• MDR Text Key: 339319145
• Report Number: 1218950-2024-00236
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: 00884838048645
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K143057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• 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?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/14/2024
• Supplement Dates FDA Received: 04/23/2024
• 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