MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70

Model Number M8007A

Device Problem Delayed Alarm (1011)

Patient Problem Cardiac Arrest (1762)

Event Date 06/20/2023

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that the alarms were not forwarded to the phones carried by nurses or were not forwarded in a timely manner.The device was in use at time of event, and a patient died.

Manufacturer Narrative

At the time of the event, the hospital claimed the monitor did not send an alarm to the nurse phone while it was in companion mode with the device.A philips field service engineer (fse) went onsite to evaluate the devices in question.The fse tested the monitor with spo2 simulator and during the test it alarmed correctly to the surveillance, and then finally to the nurse phone.The audit logs were retrieved from the customer to be evaluated by the philips product support engineer (pse).The pse confirmed the philips monitor (mp70) indeed functioned as intended, and the configured level 1 alarm was triggered promptly when the patient's spo2 levels dropped below the predetermined threshold.The alarm message was appropriately sent over the network to the surveillance (piic) system, which alarmed at the second level, ensuring that the relevant healthcare personnel were notified promptly.The pse also found the alarm messenger clinical workflow was set up to delay the desat alert 15 seconds and configured by the user to discard all duplicate alerts in that time frame as well.The customer claimed, the alert did not go to the nursing staff assigned and the system reset itself each time.They wanted to understand what "reset by system" meant? in response to this statement, the pse explained the iem alarm messenger was set up with the ¿alert delay feature¿.If the dispatched instant ix alert is canceled in the delay period nothing will be sent to the end devices by clinical design setup in the workflow configuration of the system.During the investigation, our team thoroughly examined the audit logs and configuration related to desat conditions within the iem (inteliview enterprise management) system.It was observed that the system was equipped with a 15-second delay for alarm escalation.This delay allows for brief fluctuations in the patient's spo2 levels, minimizing the occurrence of false alarms and prioritizing clinically significant events.Based on the logs evaluated by a philips pse, the unit performed exactly as specified and designed.The alarm messenger clinical workflow was set up to delay the desat alert 15 seconds and discard all duplicate alerts in that time frame.The device remains at customer site.

• Brand Name: INTELLIVUE MP70
• Type of Device: INTELLIVUE MP70
• 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: 17455022
• MDR Text Key: 320367617
• Report Number: 9610816-2023-00388
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• 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: M8007A
• Device Catalogue Number: M8007A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2003
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 89 KG