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

Model Number 866389

Device Problem Device Alarm System (1012)

Patient Problem Hypoxia (1918)

Event Date 03/01/2023

Event Type  Injury  

Event Description

The customer reported failure to alarm for spo2 desat.Patient had to be intubated.

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Manufacturer Narrative

Logs were pulled and reviewed by the remote clinical support specialist which required an field service engineer (fse) to go onsite.The clinical support specialist did confirm from the logs that the spo2 alarms were turned off.The fse confirmed in a good faith effort (gfe) that the customer was inquiring about how the red and yellow alarms worked.There issue has been resolved by communication with the customer and collaborating with the clinical specialist.It has been confirmed the alarms are working as expected and there is no malfunction on the pic ix.The device was functioning as intended and there is no malfunction on the device.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: 16642329
• MDR Text Key: 312284423
• Report Number: 1218950-2023-00168
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: 00884838048645
• 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: Health Professional,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: 03/01/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• 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): Required Intervention