MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX750 PATIENT MONITOR

Model Number 866471

Device Problem False Alarm (1013)

Patient Problems Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2024

Event Type  Injury  

Manufacturer Narrative

Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that an event where high priority (extreme/ red) alarms were not triggered when patients had extremely low mean arterial pressures (map).Patient in room 3303 was noted to have a map of 40 without a high priority alarm.The record reports user impact as ¿code situation for room 3303¿.The record indicates that the nurses expected red alarms to be enabled when they were not based on the device configuration.Alarm configurations were checked in room 3303 and confirmed that extreme alarms were not enabled.All devices have the same configuration.Based on the available information, there was user confusion about the alarm behavior.There is a report of patient injury.It cannot be determined with the available information if the reported code situation is alleged to be related to the disabled high priority alarms (noted to be user impact not patient impact), and limited information to determine if the reported event meets criteria for a serious injury.

Manufacturer Narrative

The following functional tests were performed: per gfe a philips remote support engineer states that the mx750 monitor was a replacement for the mp70 monitor, and it was confirmed the configuration was the same in both monitors.The configuration has extreme alarms disabled, which was discussed with the hospital staff.The staff was unable to speak to specific patient conditions or the nurse that reported the concerns of no audible alarms.The remote support engineer checked the alarm configurations in room 3303 and confirmed that extreme alarms were not enabled.All devices have the same configuration.Rse states the reported issue was a result of the nurse expecting red arterial alarms to be enable when they were not.The remote engineer advised that the staff training is required or the need for configuration changes to enable extreme red alarms for arterial labels.Based on the information available and the testing conducted, the cause of the reported problem was confirmed to be configuration issue.The intellivue mx750 patient monitor was functioning as intended and there is no malfunction on the device.The reported problem was not confirmed.Result of the clinical re-assessment performed by the pms clinical expert concludes that based on new information received in the complaint record.It was reiterated the configuration for the monitors is for red alarms to be disabled.It was clarified this pr is for the patient in 3303, for which there was as delay in care due to the nurses not noticing the yellow alarms when the arterial pressure dropped below limits.The patient coded but was revived and was in critical condition.Nurses were expecting red alarms for arterial pressure issues to be enabled but they were not.Philips clinical specialist provided the resolution of staff education and configuration changes to enable all extreme red alarms for arterial beds.Based on this information, there was no device malfunction and the device worked as configured; however, user confusion and possibly alarm management caused or contributed to the event, which meets criteria for serious injury.Based on the available information, there was user confusion about the alarm behavior.The device was confirmed to be operating per specifications and no malfunction was identified upon checks.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 MX750 PATIENT MONITOR
• Type of Device: INTELLIVUE MX750 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: 19200649
• MDR Text Key: 341246990
• Report Number: 9610816-2024-00233
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838083332
• UDI-Public: 00884838083332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210906
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866471
• Device Catalogue Number: 866471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• 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): Required Intervention