MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX400 PATIENT MONITOR

Model Number 866060 (MX400)

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that on (b)(6) 2020 between 05:00 pm and 08:00 pm a patient suffered serious consequences.The customer requested assistance in extracting patient data.No further information about patient had been made available at the time of the reporting decision.

Manufacturer Narrative

Philips was contacted for assistance in extracting patient data from an intellivue mx400 patient monitor, as the customer admitted a patient to the pediatric emergency and then the patient died.The involved device was tested by customer's biomed and found to be working as intended.No trouble was found with the device.Philips requested further information to allow the evaluation of the reported issue.However, the alarm logs for the reported time of event were not available.No further contact was established by the customer regarding the reported device and issue.The exact cause for the reported issue remains unknown.Due to the lack of available information, a malfunction of the device cannot be ruled out.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.

Event Description

The customer reported that on friday, (b)(6) 2020 between 05:00 pm and 08:00 pm a patient was admitted to the pediatric emergency and died.The customer requested assistance in extracting patient data.

Manufacturer Narrative

H3 and h6: information was provided after initial report sent.The patient actually died and customer is looking for data.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 MX400 PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 10435856
• MDR Text Key: 203802498
• Report Number: 9610816-2020-00287
• 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,Followup
• Report Date: 08/19/2020

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: 866060 (MX400)
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 08/19/2020; 08/19/2020
• Supplement Dates FDA Received: 08/21/2020; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death