Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HSG INTELLIVUE MX40 WLAN; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS MEDICAL SYSTEMS HSG INTELLIVUE MX40 WLAN; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) Back to Search Results
Model Number MX40-WL3
Device Problems Fire (1245); Melted (1385); Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2022
Event Type  malfunction  
Event Description
The patient reported to nursing staff that the black ekg lead wire set on fire while she was wearing the device.She was in the bathroom and smelled something strange.She looked down and saw the black wire melting and then a little flame appeared.She used a wet towel to put it out.The patient reported no injury and nursing staff verified no burn.The patient reported earlier in the night she had noticed that the telemetry monitor box felt hot in her gown pocket.She took it out of her gown and laid it on the bed to cool off.The patient stated the box fell off the bed onto the ground at one point that evening.The telemetry box and leads were sequestered and delivered to biomedical engineering for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTELLIVUE MX40 WLAN
Type of Device
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS HSG
100 park avenue
suite 300
orange village OH 44122
MDR Report Key14711753
MDR Text Key294130137
Report Number14711753
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMX40-WL3
Device Catalogue Number865352
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/03/2022
Date Report to Manufacturer06/16/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age12410 DA
-
-