MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX450 PATIENT MONITOR

Model Number 866062 (MX450)

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer has reported that a patient went unmonitored on (b)(6) 2019 between 16:30 to 17:00 due to an ignored blue "ecg leads off" inop.The patient required assisted ventilation and prolonged time in the intensive care unit (icu).

Manufacturer Narrative

A philips field service engineer (fse) was dispatched to the customer site and gathered details about the patient and the event.The fse confirmed that the monitor was not connected to the patient at the time of the alleged event.The fse also confirmed that the customer's "ecg leads off" alarm/inop setting was set to blue.The customer reported to the fse that the staff were desensitized to alarms from monitors coming out of standby and alarming, which caused the "ecg leads off" inop to be ignored.The philips field service engineer (fse) discussed changing the configuration of the "ecg leads off" inop with the customer, but the customer did not want to change the inop's configuration from blue.The monitor remains in service at the customer site, and no additional information concerning the patient's outcome has been provided.No product malfunction has occurred; the customer has reported that the monitor alarmed as configured.No further investigation is required.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INTELLIVUE MX450 PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9103971
• MDR Text Key: 164083254
• Report Number: 9610816-2019-00248
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 866062 (MX450)
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 75