MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX550; PATIENT MONITOR

Model Number 866066

Device Problem No Audible Alarm (1019)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  malfunction  

Manufacturer Narrative

This is a supplemental report to mfr.Report #:1218950-2020-00559.The fda registration number initially chosen was incorrect.Please refer to this report.

Event Description

The customer reported that alarms did not sound when a male patient suffered a cardiac arrest.Further details form the nurse supervisor indicated that there was no cardiac arrest.According to the nurse supervisor, the blood pressure alarms did not sound at the bedside monitor (mx550) in box 16, when the patient had low blood pressure.The nurse supervisor stated the saturation and heart rate alarms should have sounded next due to the hypotension, but the nurse supervisor was not aware that they sounded.

• Brand Name: INTELLIVUE MX550
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9677117
• MDR Text Key: 182401144
• Report Number: 9610816-2020-00045
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038783
• UDI-Public: (01)00884838038783
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K131872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/14/2020

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: 866066
• Device Catalogue Number: 866066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• 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