MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX400 PATIENT MONITOR

Model Number 866060

Device Problem Delayed Alarm (1011)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2024

Event Type  malfunction  

Event Description

It was reported the intellivue mx400 patient monitor spo2 alarm level is not triggering alarms in a timely manner.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

The remote service engineer (rse) spoke with the customer and confirmed the reported problem.A rse instructed biomed that there is a desaturation alarm delay time and need to go into configuration mode to check the delay time.A rse also states that if the delay is at 20 seconds, then the value must go below 85 and stay below for greater than 20 seconds.The staff stated that was too long and rse informed that it is configurable so need to work with the medical director to determine the time they would like configured for the monitors.The delay can be configured to 0 if they would like but it will generate a lot of alarms.Based on the information available and the testing conducted, the cause of the reported problem seems to be an issue with alarm management.The reported problem was confirmed.The engineer provided their analysis findings and confirmed the device was working to its specifications.There was no product malfunction, only a customer dissatisfaction and wrong perception of the device functionalities.

• Brand Name: INTELLIVUE MX400 PATIENT MONITOR
• Type of Device: INTELLIVUE MX400 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: 19094884
• MDR Text Key: 340739206
• Report Number: 9610816-2024-00193
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038752
• UDI-Public: 00884838038752
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130849
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866060
• Device Catalogue Number: 866060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• 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