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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM; SYSTEM, HEMODYNAMIC, IMPLANTABLE
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ST. JUDE MEDICAL, INC. CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM; SYSTEM, HEMODYNAMIC, IMPLANTABLE Back to Search Results
Model Number CM3000
Medical Device Problem Code Thermal Decomposition of Device (1071)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 07/06/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
During analysis, evidence of electrical overstress was visually observed on the circuit board.
 
Event or Problem Description
During device analysis, evidence of electrical overstress was found on the hospital unit circuit board.The hospital unit was returned for an error 00.
 
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Brand Name
CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM
Common Device Name
SYSTEM, HEMODYNAMIC, IMPLANTABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
387 technology circle nw suite 500
atlanta GA 30313
MDR Report Key10280105
Report Number3004936110-2020-00381
Device Sequence Number16854529
Product Code MOM
UDI-Device Identifier05415067029331
UDI-Public05415067029331
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P100045
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 07/15/2020
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
Operator of Device Health Professional
Device Model NumberCM3000
Device Catalogue NumberCM3000
Device Lot Number6663719
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/06/2020
Initial Report FDA Received Date07/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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