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

Model Number 865240

Device Problem No Display/Image (1183)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

It was reported that a patient was undergoing care in the intensive care unit and the staff reported, " when alerted in another room, i could observe on the central monitor how the monitor on bed 15 suddenly went black and no more values were displayed.After i immediately went into the room, the monitor was black and rebooted automatically after about 1 1/2 minutes.No further consequences for the patient, because the failure was only short-term.The patient was ventilated at the time.".

Manufacturer Narrative

The fse performed the software patch from revision k.21.42 to revision k21.65.Based on the information available and the testing conducted, the cause of the reported problem was the software.The reported problem was confirmed.The device was operational after the software patch was performed.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 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: 17180875
• MDR Text Key: 317675317
• Report Number: 9610816-2023-00296
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838020733
• UDI-Public: 00884838020733
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• 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: 865240
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/16/2015
• 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