MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM; System, hemodynamic, implantable

Model Number	CM3000
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One cardiomems hospital electronic system was received for evaluation.Visual inspection verified a capacitor was burnt.A golden dsp board was utilized to perform all testing.The unit was powered on with no issues observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.
Event or Problem Description
This report is to advise of an event observed during analysis confirming a capacitor appeared to have been burnt.Although there were no reported visible smoke or fire, burnt components could potentially indicate evidence of fire or other elements of excess heat.There were no adverse consequences from this event and the hospital electronic system was replaced.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 387 technology circle nw suite 500; atlanta GA 30313
• Manufacturer Contact: melissa wappel ; 14900 minnetonka industrial road; minnetonka, MN 55345 ; 6517565400
• MDR Report Key: 19165644
• Report Number: 3004936110-2024-00548
• Device Sequence Number: 7873639
• Product Code: MOM
• UDI-Device Identifier: 05415067029331
• UDI-Public: (01)05415067029331(10)8681782
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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 Number: CM3000
• Device Lot Number: 8681782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown