MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX800 PATIENT MONITOR

Model Number 865240 (MX800)

Device Problem No Audible Alarm (1019)

Patient Problems Cardiopulmonary Arrest (1765); Low Oxygen Saturation (2477)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

The reported issue was investigated via remote support by a philips remote clinical applications support specialist (rcass).According to the biomed at the customer site, a member of the clinical staff was standing in front of the mx800 and saw that the spo2 value was dropping below the desat limit before returning to a level above the desat limit violation.The staff member expected a desat alarm for the drop below the desat limit which was not announced by the monitor.The rcass reviewed the audit log from the central station together with the biomed and multiple yellow spo2 alarms as well as some red desat alarms were found for the patient.The rcass advised the biomed of the alarm delay configuration of 10 seconds for a spo2 low limit alarm and 20 seconds for a desat alarm.The spo2 value returned above the desat limit threshold within the alarm delay time, which was the reason why the alarm was not indicated.The biomed stated that the clinical staff was not aware of the alarm delay functionality and that she would instruct the staff accordingly.The rcass provided the biomed with information regarding the alarm behavior to be forwarded to the clinical users.The biomed was also instructed on how to access and review the alarm review on the monitor.Additionally, the biomed advised that she had tested the monitor and found it to be working as intended.It is considered that this issue was resolved by the remote clinical application support specialist instructing the biomed regarding the alarm delay functionality and providing information regarding the alarm behavior.The monitor worked as intended and there was no malfunction of the device.This issue was caused by the alarm delay configuration.

Event Description

The customer reported that the intellivue mx800 patient monitor did not alarm for a desat as expected on (b)(6) 2021.The patient needed to be resuscitated.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 11223347
• MDR Text Key: 228452026
• Report Number: 9610816-2021-00024
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/06/2021

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: 865240 (MX800)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2013
• 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