MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP90

Model Number 862452

Device Problem Defective Alarm (1014)

Patient Problem Hypoxia (1918)

Event Date 11/30/2022

Event Type  Injury  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer is requesting the bedside monitor log file review due to alarms and the spo2 limits in question following a patient's mother reporting the baby's spo2 saturation dropped to 70 and the baby turned blue.The field service engineer (fse) went to the customer's site and collected the device logs.The fse reported per the clinical audit trail around the reported time of the event 1:00 pm there was a desat alarm generated.There was no other alarm activity around 1:00 pm.Only one minute of vital signs are available; therefore, they are unable to show how long the spo2 may have been below 85, to trigger a desat event.The fse tested the alarms and found the spo2 alarms functioned as expected.The fse also verified the spo2 alarm limits were set at 93 for low spo2 and 85 for the desat alarm since (b)(6) 2022.

Event Description

This report is based on information provided by philips field service personnel and has been investigated by the philips complaint handling team.Philips received a complaint indicating that the monitor did not alarm when the baby's oxygen saturation (spo2) dropped to 70, and the baby turned blue.The patient was not harmed nor did any injury occur, and the patient did not undergo any medical or surgical interventions.The philips field service engineer (fse) went onsite and tested the alarms and found that the spo2 alarms functioned as expected.There were many spo2 related alarms, physiological patient related alarms and technical alarms.Based on the information available and the testing conducted, the cause of the reported problem was the user, because the spo2 alarms were silenced by the user.The device was confirmed to be operating per specifications and no failure was identified.

• Brand Name: INTELLIVUE MP90
• Type of Device: INTELLIVUE MP90
• 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: jeanne ahearn ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16077642
• MDR Text Key: 306423096
• Report Number: 9610816-2022-00665
• 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: 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: 862452
• Device Catalogue Number: 862452
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2008
• 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; Life Threatening
• Patient Age: 2 YR
• Patient Sex: Male