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

Model Number 865240

Device Problem Unable to Obtain Readings (1516)

Patient Problem Cardiac Arrest (1762)

Event Date 08/18/2023

Event Type  Death  

Event Description

The customer reported that patient expired while monitored on mx800 during surgical activity.No record of patient activity during final moments before patient expiration.

Manufacturer Narrative

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

Manufacturer Narrative

The complaint was escalated for technical investigation and the results indicate that the monitor in question was set up as a standalone monitor with no connection to a database, so recordings were not available after the event.The product support engineer (pse) advised that this is not a product malfunction, and the monitor was functioning as designed.The pse explained that the mx800 can be setup/configured to send information to a database.However, in this case, the monitor has not been set up to do so and/or the customer has not the infrastructure to record data coming out of the monitor.The project manager (pm) was sent the information, and he advised that if we consider the trend as patient activity, we could say that the mx800 could record the patient activity at 1 value every 12 seconds.If the user is considering patient activity as continuous waves and numeric records, so in that case mx800 is not capable of a such report as long as not connected to any database (such as picix).The device was functioning as intended and there is no malfunction on the device.The device was confirmed to be operating per specifications and no failure was identified.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 17733783
• MDR Text Key: 323246039
• Report Number: 9610816-2023-00459
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838020733
• UDI-Public: 00884838020733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• 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 Model Number: 865240
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2018
• 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): Death