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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; HOSPITAL DIAGNOSTIC PROGRAMMER
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ST. JUDE MEDICAL, INC. - CARDIOMEMS CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM; HOSPITAL DIAGNOSTIC PROGRAMMER 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)
Date of Event 04/26/2019
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 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.
 
Additional Manufacturer Narrative
During analysis, the error 05 was confirmed and reproduced.Once the software settings were updated, the error did not recur.
 
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Brand Name
CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM
Common Device Name
HOSPITAL DIAGNOSTIC PROGRAMMER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC. - CARDIOMEMS
387 technology circle nw suite 500
atlanta GA 30313
MDR Report Key8578354
Report Number3004936110-2019-00247
Device Sequence Number11349500
Product Code MOM
UDI-Device Identifier05415067029331
UDI-Public05415067029331
Combination Product (Y/N)N
Initial Reporter StateWI
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 Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date (Section B) 11/04/2019
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 Number6511546
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2019
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 04/26/2019
Supplement Date Received by Manufacturer11/01/2019
Initial Report FDA Received Date05/03/2019
Supplement Report FDA Received Date11/04/2019
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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