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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM; HOSPITAL DIAGNOSTIC PROGRAMMER
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ST. JUDE MEDICAL, INC. CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM; HOSPITAL DIAGNOSTIC PROGRAMMER Back to Search Results
Model Number CM3000
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/05/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The cardiomems hospital electronic system was received for evaluation.No anomalies were found during visual inspection and the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Diagnostic testing confirmed the reported event.
 
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.
 
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Brand Name
CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM
Common Device Name
HOSPITAL DIAGNOSTIC PROGRAMMER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
387 technology circle nw suite 500
atlanta GA 30313
MDR Report Key9027017
Report Number3004936110-2019-00465
Device Sequence Number2588987
Product Code MOM
UDI-Device Identifier05415067029331
UDI-Public05415067029331
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
P100045
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date (Section B) 09/13/2019
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? No
Operator of Device No Information
Device Model NumberCM3000
Device Lot Number6211694
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2019
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/27/2019
Initial Report FDA Received Date09/13/2019
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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