MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX450 PATIENT MONITOR

Model Number 866062

Device Problem Alarm Not Visible (1022)

Patient Problem Hypoxia (1918)

Event Date 06/20/2023

Event Type  Injury  

Event Description

The customer reported that an audible desaturation alarm was generated on the intellivue mx450 patient monitor and silenced by the clinical staff, but the alarm was not visible on the monitor.The device was in use monitoring a patient at the time of the reported event.The patient desaturated, but recovered.

Manufacturer Narrative

Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).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.

Manufacturer Narrative

A philips clinical application specialist (cas) went to the customer site to evaluate the device and perform research on the cause of the alleged device missing recording a visual alarm.The (cas) performed analysis of screenshots from the pic ix, results of clinical audit trail and configuration of the intellivue mx450 on which the incident occurred.This data was provided by the hospital biomed (with the research performed by the biomed).Based on additional information and the clinical audit log review by a clinical application specialist, the nurse was in the room at the time of the incident.The patient was visibly cyanotic and the monitor generated and alarm, which was silenced by the nurse.It was indicated that yellow and red alarms are visually latched.The patient continued to have a low oxygen saturation so the visual alarm remained on the screen.The patient then recovered from the desaturation but experienced another period of desaturation later, for which the monitor generated an audible alarm, which was silenced by the nurse.When the nurse went to look at the alarm, they were not able to find it; however, since the alarm condition had continued previously, the visual alarm had not been cleared once the patient initially recovered.This means the second desaturation was not logged as the previous desaturation event was still visually latched and present in the logs.It was suggested the customer change their configuration to stop visual latching.This means when the alarm condition stops, the notification is ended.If the patient's condition meets the threshold again, a new visual and audible alarm will be generated.Then each new event will be captured in the logs.Based on this information, there was no harm to the patient as alarms were generated and the nurse was at the bedside.The reported issue was more of a question on alarm behavior.The engineer provided his analysis findings.The device worked according to specifications.There was no malfunction of the device, but a misunderstanding on the part of the customer on the meaning of and implications of the monitor configuration settings for alarms latching.Based on the information available and the testing conducted, philips intellivue mx450 patient monitor and pic ix devices have not caused or contributed to the event; however, alarm configuration awareness may have been a contributing factor.The cas instructed the customer that to prevent this situation from happening again the following must be done: "stop the visual latching of the alarms.When an alarm stops the notification is ended in the mx450 and the pic ix.If the patient will go through the alarm threshold the mx450 will sound a new visual and audible alarm, a new event will be made in the pic ix, and the nurse will be able to look form the alarm in the pic ix.".

• Brand Name: INTELLIVUE MX450 PATIENT MONITOR
• Type of Device: INTELLIVUE MX450 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: 17207327
• MDR Text Key: 317903398
• Report Number: 9610816-2023-00307
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038769
• UDI-Public: 00884838038769
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• 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: 866062
• Device Catalogue Number: 866062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2018
• 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
• Patient Age: 9 MO
• Patient Sex: Male
• Patient Weight: 6 KG