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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS; PATIENT MONITOR
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PHILIPS MEDICAL SYSTEMS PHILIPS; PATIENT MONITOR Back to Search Results
Model Number 863301
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer contacted the customer care solution center and alleged an unspecified blue alarm on the complaint device and requested support.The complaint device was not in clinical use at the time that the issue was discovered.
 
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Brand Name
PHILIPS
Type of Device
PATIENT 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 Key10150015
MDR Text Key195373142
Report Number1218950-2020-03421
Device Sequence Number1
Product Code MHX
UDI-Device Identifier00884838035218
UDI-Public(01)00884838035218
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K151812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number863301
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/04/2020
Initial Date FDA Received06/12/2020
Supplement Dates Manufacturer Received06/04/2020
Supplement Dates FDA Received06/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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