MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX750 PATIENT MONITOR

Model Number 866471

Device Problem Display Difficult to Read (1181)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2022

Event Type  Injury  

Event Description

It was reported that the bed to bed overview screen that pops up is too small and it blends in with the background of the current monitors waveforms.The customer mentioned that this is difficult to see across the room.The device was in use on a patient at the time of the reported issue.Patient outcome is currently unknown.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that the bed to bed overview screen that pops up is too small and it blends in with the background of the current monitors waveforms.The customer mentioned that this is difficult to see across the room philips has obtained further information through the help of the a clinical specialist for the intellivue monitors.The cs determined that the monitor itself is what determines the size of the font that is used and that there is no setting that can change that on the monitor.The customer was complaining that the size was different on two different size monitors for the mp70 and mx700, which would be as expected for the devices.Based on the cs's investigation into the size of the monitors it was determined that there was no product malfunction for the issue and is considered a user issue.From the review of the pixel size of the monitors and the inability of the devices to change size of font, the issue will persist for the customer as a non malfunction.No further investigation was warranted as no harm was alleged by the customer.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: INTELLIVUE MX750 PATIENT MONITOR
• Type of Device: INTELLIVUE MX750 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14956227
• MDR Text Key: 295486816
• Report Number: 9610816-2022-00366
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838083332
• UDI-Public: 00884838083332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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: 866471
• Device Catalogue Number: 866471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• 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