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

Model Number 865240

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2023

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.

Event Description

It was reported the customer requested assistance with obtaining clinical audit logs following a patient death.It was indicated by the clinical manager that the bedside monitor with monitor label: ub 7746 may be involved and an investigation is underway.The device was in use on a patient.There was a report of patient harm.

Manufacturer Narrative

Philips received a complaint on the intellivue mx800 patient monitor indicating the customer is requesting assistance with obtaining clinical audit logs following a patient death.The following functional tests were performed: per hospital it support clinical manager investigating a patient's death, the customer indicate the need to review the historical stored history for timeframe p10/18 to (b)(6) 2023.Customer stated 2 bedside monitors - ub 7746 and ub 7748 might be involved.Customer is not sure if the details and if this event involved the philips monitors, so they need to review the history for this period.The remote clinical support explained that the patient data is stored for up to seven days for each patient on the system during the patient stay, and upon discharge from the system after which the patient's history would be purged.The field engineer (fse) retrieved the unit clinical audit logs, picix logs and bedside configuration.Fse worked with hospital biomed to test bedside alarms, results verified ecg and sp02 alarms working at pic ix and bedside.Based on the information available and the testing conducted, the cause of the reported problem was not confirmed.A clinical assessment was performed based on the information currently available in the complaint record.It was reported the customer requested assistance with obtaining clinical audit logs following a patient death.It was indicated by the clinical manager the two bedside monitors may be involved.However, there was no specific information related to the monitor involvement.Based on the information available and results of additional analysis, no further action is necessary at this time.A review of the risk management file was performed and determined the following: the device has been alleged or indicated to have caused or contributed to a death or serious injury therefore the device may have been a factor in the event and the event is therefore reportable.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.Based on findings provided in the case, it was impossible to retrieved the patient's history for time frame (b)(6) 2023 as requested by the customer as the pic ix only holds bed data for 7 days, and at the time of the customers request the data is long gone out of the pic.However the field engineer and the biomed verified the device to be operating per specifications.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: 18191089
• MDR Text Key: 328793046
• Report Number: 9610816-2023-00616
• Device Sequence Number: 1
• Product Code: MHX
• 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: 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

• Date FDA Received: 11/22/2023
• 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
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2017
• 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