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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS EXPRESSION PATIENT MONITOR (MR400)
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INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS EXPRESSION PATIENT MONITOR (MR400) Back to Search Results
Model Number 866185
Medical Device Problem Code Thermal Decomposition of Device (1071)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/09/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event or Problem Description
The customer contacted the customer care solution center and alleged that the complaint device module was apparently burnt and requested support.The complaint device was not in clinical use at the time that the issue was discovered.
 
Event or Problem Description
The customer contacted the customer care solution center and alleged that the complaint device module was apparently burnt and requested support.The complaint device was not in clinical use at the time that the issue was discovered.There was no adverse event or patient harm reported.
 
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Brand Name
EXPRESSION PATIENT MONITOR (MR400)
Common Device Name
EXPRESSION PATIENT MONITOR (MR400)
Manufacturer (Section D)
INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS
12151 research parkway
orlando FL 32826
MDR Report Key12268002
Report Number1051786-2021-10041
Device Sequence Number11856407
Product Code MWI
UDI-Device Identifier00884838039131
UDI-Public00884838039131
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K152330
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial 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
Operator of Device No Information
Device Model Number866185
Device Catalogue Number866185
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date07/09/2021
Initial Date Received by Manufacturer 07/09/2021
Supplement Date Received by Manufacturer07/09/2021
Initial Report FDA Received Date08/03/2021
Supplement Report FDA Received Date10/09/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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