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

Model Number 866389

Device Problem Defective Alarm (1014)

Patient Problem Hypoxia (1918)

Event Date 04/18/2023

Event Type  Injury  

Event Description

The customer reported the alarms did no occur for a desaturation event.The infant patient was turned blue after developing severe hypoxia and oxygen was applied to the patient to resolve the issue.

Manufacturer Narrative

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

Manufacturer Narrative

The logs have been pulled and reviewed by the response service engineer (rse).The clinical log analysis from the rse: ¿to access the menu for latched audio and visuals, go to main setup, then alarm, then alarm settings: visual latched and audio not latched.In this case, the red desaturation alarm is generated at 20:32 and 36 seconds, it was never acknowledged until 21:46 and 29 seconds.Since the first alarm at 20:32 and 36 seconds was not acknowledged, not only is the second alarm not listed in the alarm log or in the audit trail of the central unit, but no record is available for this alarm.Furthermore, the mp5 is configured in visual blocked and audio unblocked mode, so the reappearance of the alarm condition generated a new audible alarm and the corresponding alarm light flashed, but since the first alarm was never acknowledged, there is no trace in the logs.The expected result is to have a trace in the logs that the alarm has beeped a second time.¿ due to the alarm not being acknowledged this would be considered a user error.The device was confirmed to be operating per specifications and no failure was identified.

• 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: 16793905
• MDR Text Key: 313802578
• Report Number: 1218950-2023-00252
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 04/18/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening