MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX550 PATIENT MONITOR

Model Number 866066

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Cardiac Arrest (1762)

Event Date 04/20/2023

Event Type  Injury  

Event Description

The customer reported that on (b)(6) 2023 around 10:30am, a patient experienced a cardiac arrest.Through the clinical audit log extracted from the monitoring central on which the monitor is connected through bed 15, they were able to check that both the central and the monitor sounded the "xbradi 51<55" alarm generated in 10:24:43 pm on (b)(6) 2023 right after the "asystole" alarm generated at 10:24:52.On (b)(6) 2023 it was noted that the device was manually silenced by a user using the monitor at 10:26am on (b)(6) 2023.It was questioned by the nurse that when they went to service the patient and they found that the spo2 parameter had a saturation alarm that was deactivated in the monitor.Through the central station's clinical audit log, was found that the spo2 alarm was deactivated by the user directly on the on (b)(6) 2023 at 07:09pm.

Manufacturer Narrative

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

Event Description

Philips received a complaint on the intellivue mx550 patient monitor indicating that there was an adverse event, where a patient experienced cardiac arrest on (b)(6) 2023.The patient was resuscitated, and his vital signs were stable.

Manufacturer Narrative

The philips field service engineer (fse) went onsite and analyzed the bedside monitor.Through the clinical log, the fse determined that the monitor sounded the "xbradi 51<55" alarm at 10:24:43 am right after the "asystole" alarm generated at 10:24:52 am.The alarm was manually silenced by a user using the monitor at 10:26 am.The fse found the spo2 parameter had a saturation alarm deactivated in the monitor.The central station's clinical audit log showed that the spo2 alarm was deactivated by the user directly on the (b)(6) 2023 at 07:09 pm.The fse carried out sound and visual alarm tests on the monitor and the monitoring and no anomaly in its software or hardware was diagnosed.The monitor was 100% functional.Based on the information available and the testing conducted, the cause of the reported problem was user, as the user silenced the alarms.The reported problem was confirmed.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 MX550 PATIENT MONITOR
• Type of Device: INTELLIVUE MX550 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: 16876006
• MDR Text Key: 314631452
• Report Number: 9610816-2023-00206
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038783
• UDI-Public: 00884838038783
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K131872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 866066
• Device Catalogue Number: 866066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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): Other; Required Intervention
• Patient Sex: Male