MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR; INTELLIVUE PATIENT MONITOR MX800

Model Number 865240

Device Problems Device Alarm System (1012); No Visual Prompts/Feedback (4021)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon receipt of additional information.

Event Description

It was reported that after installation of the central, the device gets no alarm.It is unknown if the device was in clinical use or patient involvement at the time of the event.Additional information is pending.

Manufacturer Narrative

Based on additional information received, there is no indication that the device failed to alarm, as was initially reported.The issue was related to the customers preference to have alarms displayed in red, rather than blue.This case no longer meets the definition of a reportable event.

Event Description

Philips received a complaint on the intellivue patient monitor mx800 indicating that ¿the device gets no alarm¿.A good faith effort was completed to obtain additional clarity regarding the alleged device issue.A response was received from the response service engineer (rse) indicating the original problem description received ¿the device gets no alarm¿ was incorrect.Per the rse, the customer only requested assistance updating the configuration of the device so that invasive blood pressure inops display in red instead of blue.It is unknown if the device was in clinical use or patient involvement at the time of the event.Functional analysis was performed by an application specialist and identified no problem with the device.The device configuration was updated so that future invasive blood pressure inops would display in red as requested by the customer.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE PATIENT MONITOR MX800
• 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: 15495299
• MDR Text Key: 300708737
• Report Number: 9610816-2022-00498
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838020733
• UDI-Public: 00884838020733
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865240
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/13/2022
• Date Device Manufactured: 04/27/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1