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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC EFFICIA CM120
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PHILIPS NORTH AMERICA LLC EFFICIA CM120 Back to Search Results
Model Number 863302
Device Problem Device Fell (4014)
Patient Problem Insufficient Information (4580)
Event Date 07/14/2022
Event Type  malfunction  
Event Description
It was reported to philips that the device fell and is damaged.Patient involvement is unknown.
 
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips that device defective, fall damage.Patient involvement is unknown.
 
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Brand Name
EFFICIA CM120
Type of Device
EFFICIA CM120
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
tara mackinnon
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key15129292
MDR Text Key296878746
Report Number1218950-2022-00649
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K151812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Biomedical Engineer
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 Operator Health Professional
Device Model Number863302
Device Catalogue Number863302
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/14/2022
Initial Date FDA Received07/29/2022
Supplement Dates Manufacturer Received09/02/2022
Supplement Dates FDA Received09/08/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/11/2017
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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