MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH INTELLIVUE PATIENT MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number MX800865240

Device Problem Device Alarm System (1012)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/09/2023

Event Type  malfunction  

Event Description

Blood pressure dropped, no blood pressure monitor alarms sounded or alarmed.

• Brand Name: INTELLIVUE PATIENT MONITOR
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
• MDR Report Key: 16379370
• MDR Text Key: 309664594
• Report Number: MW5114938
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/09/2023

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 Operator: Health Professional
• Device Model Number: MX800865240
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2023
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female