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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. - CARDIOMEMS CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM; CARDIOMEMS HOPSITAL ELECTRONIC SYSTEM
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ST. JUDE MEDICAL, INC. - CARDIOMEMS CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM; CARDIOMEMS HOPSITAL ELECTRONIC SYSTEM Back to Search Results
Model Number CM3000
Medical Device Problem Code Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device is included in the error 5 advisory notice issued by abbott on 01 june 2018.
 
Event or Problem Description
It was reported (b)(6) that the hospital electronic unit received an error 5 message, which indicates an issue related to temperature and barometric pressure.A replacement unit may resolve the issue.
 
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Brand Name
CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM
Common Device Name
CARDIOMEMS HOPSITAL ELECTRONIC SYSTEM
Manufacturer (Section D)
ST. JUDE MEDICAL, INC. - CARDIOMEMS
387 technology circle nw suite 500
atlanta GA 30313
MDR Report Key8143968
Report Number3004936110-2018-02019
Device Sequence Number11240322
Product Code MOM
UDI-Device Identifier05415067029331
UDI-Public05415067029331
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
P100045
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date (Section B) 12/07/2018
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 Number6204250
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/15/2018
Initial Report FDA Received Date12/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		3004936110-06/01/18-001R
Patient Sequence Number1
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