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 07/17/2023

Event Type  Injury  

Manufacturer Narrative

The issue esd discussed with the customer and captured log data associated with this event.The rse reviewed the log associated with this event to determine if the system functioned as intended , when looking at the system, it shows the sensor had difficulties initially with capturing the spo2 measurement, but the medical teams were aware of the desaturation of the patient in room 5 in view of the numerous acknowledgments in room 5 and at the central unit.The desaturation and low saturation limits have also been modified.The monitor was also turned off while a red alarm sounded at the plant.A good faith effort (gfe) confirmed further that there was no malfunction on the on the piic device.He also confirmed harm to the patient was hypoxia , but nothing serious according to the customer.Based on the information available and the testing conducted, the device was functioning as intended and there is no malfunction on the device.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be re-opened.

Event Description

The customer reported that the patient had a desaturation event of 84% with no audio or visual alarm.This was followed by a second desaturation event of 80% with no visual or audible alarm.It is unclear if there was a serious injury or not; therefore, it will be reported conservatively.

• 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: 17514725
• MDR Text Key: 321041344
• Report Number: 1218950-2023-00560
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K183387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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?: No
• 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: 07/17/2023
• Initial Date FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other