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

Model Number 865240

Device Problem No Audible Alarm (1019)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

The philips fse reviewed the logs & according to the logs, the alarm sound and someone silenced it in the room on the monitor.The biomed informed the fse that the yellow alarm was seen but they did not respond to it because it was still showing a pressure.They said that it did not tell them that the patient was leaking blood until it was completely pulled out of the patient¿s arm.That¿s when the nurse responded and found out that the patient had been leaking blood.The biomed confirmed that the monitor is working perfectly.They tested the alarm system to find out how long it would take for the alarm to sound if the line was pulled out and it would take six seconds proximately once the line was completely removed.Clinical re-assessment was performed by the pms clinical expert based on new information received in the complaint record.Additional information was reviewed.This additional information reiterated the alarm was not generated for a disconnected arterial line; however, biomed stated the nursing staff indicated the yellow alarm was visualized but they did not respond to the alarm as a pressure was still displayed.At that time, the patient extubated himself and an alarm for the ventilator brought nurses to the bedside, where they discovered the arterial line was still in the artery but was bleeding profusely at the site.Pressure was held on the site, which caused a high pressure to display, and the arterial line was subsequently removed.The patient lost approximately 500-600cc of blood, which required a blood transfusion.Biomed tested the device with a simulator, revealing the device performed as designed.Based on this information, it does not appear there is a device issue; however, as staff did not respond to the generated alarms, a combination of use error, alarm management, and clinical workflow in which the device was used may have been factors in the reported event.The customer biomed confirmed that the monitor is working perfectly, the alarm sound and someone silenced it in the room on the monitor.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

It was reported the patient's invasive blood pressure (ibp) line became disconnected at approximately 0212am and there were no alarms generated at the central station or the bedside monitor.It was thought by the customer the patient disconnected the ventilator, which alarmed at 0220 am, which alerted staff to come to the patient room.The disconnected ibp was discovered and a blood transfusion was required due to patient blood loss.It was noted the mean blood pressure did not go down to 10 mmhg until 0220am, for which monitor generated an alarm for the pressure disconnect.The current status of the patient is unknown.

• 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: 18980062
• MDR Text Key: 338619718
• Report Number: 9610816-2024-00170
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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?: No
• 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: 02/27/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2014
• 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