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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS INTELLIVUE MMS; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
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PHILIPS NORTH AMERICA LLC PHILIPS INTELLIVUE MMS; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) Back to Search Results
Model Number M3001A
Device Problem Device Alarm System (1012)
Patient Problems Bradycardia (1751); Death (1802); Diabetic Ketoacidosis (2364); Low Oxygen Saturation (2477)
Event Date 07/08/2020
Event Type  Death  
Event Description
Suspect alarm was not working.This (b)(6) yo patient was admitted with dka (b)(6) 2020.On (b)(6) 2020, between 0252-0314, the patient was desaturating from the mid 90s to the 50s as evidenced by monitor strip data.Despite patient's desaturations and eventual bradycardia progressing to a code blue, these events were not being captured by the alarms.Review of philips alarm data showed there was no alarming during this timeframe when clearly there should have been alarming.History of type 1 diabetes, hashimoto's thyroiditis, and obesity.Learned 2 days after patient expired, he was covid positive.Fda safety report id# (b)(4).
 
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Brand Name
PHILIPS INTELLIVUE MMS
Type of Device
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
cambridge MA
MDR Report Key10395695
MDR Text Key202534573
Report NumberMW5095998
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/07/2020
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? No
Device Operator Health Professional
Device Model NumberM3001A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2020
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age19 YR
Patient Weight80
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