Health product recall

Philips IntelliVue Patient Monitors

Last updated

Summary

Product
Philips IntelliVue Patient Monitors
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
IntelliVue MP40 Patient Monitor System - Main Unit More than 10 numbers, contact manufacturer. M8003A
IntelliVue MX400 Patient Monitor More than 10 numbers, contact manufacturer. 866060
IntelliVue MX850 Patient Monitor More than 10 numbers, contact manufacturer. 866470
IntelliVue MP70 Patient Monitor System - Main Unit More than 10 numbers, contact manufacturer. M8007A
IntelliVue MX Patient Monitor System - Main Unit More than 10 numbers, contact manufacturer. MX700
IntelliVue MP60 Patient Monitor System - Main Unit More than 10 numbers, contact manufacturer. M8005A
IntelliVue MP20 Patient Monitor System More than 10 numbers, contact manufacturer. M8001A
IntelliVue MP5 Patient Monitor System - Main Unit More than 10 numbers, contact manufacturer. M8105A
IntelliVue X2 Multi-Measurement Module - Main Unit More than 10 numbers, contact manufacturer. M3002A
IntelliVue MP90 Patient Monitor System - Main Unit More than 10 numbers, contact manufacturer. M8010A
IntelliVue MP30 Patient Monitor System More than 10 numbers, contact manufacturer. M8002A
IntelliVue MP80 Patient Monitor System - Main Unit More than 10 numbers, contact manufacturer. M8008A
IntelliVue MP50 Patient Monitor System - Main Unit More than 10 numbers, contact manufacturer. M8004A
IntelliVue MP2 Patient Monitor - Main Unit More than 10 numbers, contact manufacturer. M8102A
IntelliVue MX550 Patient Monitor More than 10 numbers, contact manufacturer. 866066
IntelliVue MX750 Patient Monitor More than 10 numbers, contact manufacturer. 866471
IntelliVue MX500 Patient Monitor More than 10 numbers, contact manufacturer. 866064
IntelliVue Patient Monitor More than 10 numbers, contact manufacturer. 866062
IntelliVue MX Patient Monitor System - Main Unit More than 10 numbers, contact manufacturer. MX800

Issue

Philips IntelliVue patient monitors provide a feature for pausing all alarms for a configured timeframe or for switching all alarms off for an infinite period until they are switched back on by the user. 

The infinite alarms off feature is an important functionality in specific clinical environments such as the operating room, cath lab or during resuscitations to reduce the audible alarms which may present unnecessary distractions during closely monitored procedures or interventions. 

Philips has received complaints that the IntelliVue monitors did not alarm. In some cases, these complaints alleged delayed patient treatment due to the monitors not alarming; and, in some cases, there were reports of severe patient harm or death. It was determined that in these instances the alarms had been switched off for an infinite period, and the user may have been unaware that the alarms were off.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Health products - Medical devices - General hospital and personal use
Companies
Philips Medizin Systeme Boblingen Gmbh
Hewlett-Packard Strasse 2, Boblingen, Germany, 71034
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81234

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