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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 802.11A/B/G PATIENT MONITOR

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PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 802.11A/B/G PATIENT MONITOR Back to Search Results
Model Number 865352
Device Problems Device Alarm System (1012); Communication or Transmission Problem (2896)
Patient Problem Loss of consciousness (2418)
Event Date 02/24/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The customer reported a patient death that occurred on (b)(6) 2019. The nurses found the patient unresponsive between 01:15 and 01:30. It was alleged that the alarm messages were not being forwarded to the central station from the mx40 telemetry device.

 
Manufacturer Narrative

In a review of the clinical audit logs for (b)(6) 2019 between 00:41:54 and 01:42:42 there were 132 ecg "leads off" technical alerts generated at the central station for this patient. The alarms were silenced 70 times by the users through user interaction with the central station ix device. The field service engineer (fse) gathered the piic ix clinical audit logs and reviewed the data. He stated that the reason why there were no alarms for this patient event was that the green and black iec leads were disconnected from the patient. Thus there was no ecg monitoring. The nurses were alerted to the issue via multiple technical "leads off" alarms annunciated at the central station. The fse stated that the patient details were not allowed to be provided by the site. There is no data to support a device malfunction.

 
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Brand NameINTELLIVUE MX40 802.11A/B/G
Type of DevicePATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8399282
MDR Text Key138113080
Report Number1218950-2019-01825
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberK113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 02/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number865352
Device Catalogue Number865352
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/25/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/10/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/07/2019 Patient Sequence Number: 1
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