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

Model Number 865240

Device Problem Device Alarm System (1012)

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

Event Date 08/05/2022

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that a desaturation alarm silenced itself on the intellivue mx800 patient monitor without user interaction on 05-august-2022.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.

Event Description

The configuration files were reviewed by a philips clinical product specialist (cps).The alarms settings are set to latch for red alarm and realarm at 1 min.This means that the alarm must be silenced by the user before it would stop on its own.The realarm setting is what happens if the alarm condition continues after 1 min.The alarm delay setting for desaturation is 10 seconds.This means that the desaturation condition would have to last for 10 seconds before the alarm would occur.Audit logs and pic data were requested but were unable to be obtained.Therefore we are unable to confirm whether or not the desat condition lasted for longer than 10 seconds and whether or not the alarm silenced itself.The customer moved the patient to another monitor.The reported issue was unable to be confirmed due to lack of information - the audit logs were unable to be obtained and reviewed.Therefore, the cause of the reported issue remains unknown.No further investigation or action is warranted at this time.

• 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, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 15327472
• MDR Text Key: 301032601
• Report Number: 9610816-2022-00472
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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