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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP20 INTELLIVUE PATIENT MONITOR; COMPACT PATIENT MONITOR
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PHILIPS MEDICAL SYSTEMS MP20 INTELLIVUE PATIENT MONITOR; COMPACT PATIENT MONITOR Back to Search Results
Model Number M8001A
Device Problem Defective Alarm (1014)
Patient Problem Loss Of Pulse (2562)
Event Date 05/20/2019
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer has reported that their monitor failed to alarm after the patient had no heartbeat.The patient received emergency treatment by medical staff and his heartbeat was revived.
 
Manufacturer Narrative
Dr.(b)(6), the site's chief nurse of the intensive care unit, informed philips that the operator of the device had turned the alarms off, which lead to the alleged failure to alarm.The device's alarms were turned on and set to operate as intended.No product malfunction of the patient monitor has occurred, and no parts were replaced.The device remains at the customer site.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.
 
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Brand Name
MP20 INTELLIVUE PATIENT MONITOR
Type of Device
COMPACT PATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
MDR Report Key8679715
MDR Text Key147371759
Report Number9610816-2019-00150
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
PMA/PMN Number
K030038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 05/20/2019
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 NumberM8001A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/20/2019
Initial Date FDA Received06/07/2019
Supplement Dates Manufacturer Received05/20/2019
Supplement Dates FDA Received06/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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