MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX (PIC IX); MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number 866424

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/18/2023

Event Type  malfunction  

Event Description

Central monitors went down after equipment update.Patient oxygen saturation dropped to 84% while sleeping.Monitor in room alarming, but not central monitor.Oxygen then applied as appropriate.Unable to monitor all patients in emergency department (ed) during downtime.

• Brand Name: PATIENT INFORMATION CENTER IX (PIC IX)
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 12151 research pkwy; orlando FL 32826
• MDR Report Key: 17711091
• MDR Text Key: 322968391
• Report Number: 17711091
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 866424
• Device Catalogue Number: 866424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1