MAUDE Adverse Event Report: PHILIPS INTELLIVUE; MONITOR, PHYSIOLOGICAL, PATIENT

Model Number MP70

Device Problems Loss of Power (1475); Computer Operating System Problem (2898)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2019

Event Type  malfunction  

Event Description

Patient located in icu and is constantly monitored.The patient monitor shut itself off into standby mode from around 2253 to about 2304, which resulted in the patient not being monitored for that time.

• Brand Name: INTELLIVUE
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT
• Manufacturer (Section D): PHILIPS; 3000 minuteman road; mail stop 4202; andover MA 01810
• MDR Report Key: 8989934
• MDR Text Key: 157365150
• Report Number: 8989934
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MP70
• 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: 08/28/2019
• Device Age: 13 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1