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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC EFFICIA CM12
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PHILIPS NORTH AMERICA LLC EFFICIA CM12 Back to Search Results
Model Number 863303
Device Problem High Readings (2459)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2022
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips that the machine had high nibp readings.The device was in use on a patient.There was no report of patient or user harm.
 
Event Description
It was reported to philips that the machine had high nibp readings, the device was in clinical use at the time the issue was discovered, there was no report of patient or user harm.
 
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Brand Name
EFFICIA CM12
Type of Device
EFFICIA CM12
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer Contact
derek sammarco
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key14137285
MDR Text Key289458348
Report Number1218950-2022-00344
Device Sequence Number1
Product Code MHX
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 Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
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 Model Number863303
Device Catalogue Number863303
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/02/2022
Initial Date FDA Received04/18/2022
Supplement Dates Manufacturer Received04/02/2022
Supplement Dates FDA Received08/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2019
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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