MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX700 PATIENT MONITOR

Model Number 865241

Device Problem Alarm Not Visible (1022)

Patient Problems Cyanosis (1798); Loss of consciousness (2418); Low Oxygen Saturation (2477)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that on (b)(6) 2020 10:22 pm the intellivue mx700 patient monitor failed to alarm for saturation (spo2) low.A female patient baby 35 month, (b)(6) kg.Patient baby found unresponsive and blue patient care was escalated.

Manufacturer Narrative

There was no product malfunction of the philips intellivue mx700 patient monitor this is considered a user issue, as the alarms were seen to have occurred at the piic ix and silenced by the user at the bedsite monitor.The spo2 alarm is a lower priority alarm than higher level red alarms occurring at the same time; therefore, the spo2 alarm would not be seen by the user.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INTELLIVUE MX700 PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 10411161
• MDR Text Key: 203091878
• Report Number: 9610816-2020-00282
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838029088
• UDI-Public: (01)00884838029088
• Combination Product (y/n): N
• PMA/PMN Number: K110622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/25/2020

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: 865241
• Device Catalogue Number: 865241
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 07/25/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 35 MO
• Patient Weight: 9