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

Model Number	CM3000
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of an event observed during analysis confirming exposed wires of the printer serial cable.
Additional Manufacturer Narrative
One cardiomems hospital electronic system was received for evaluation.Visual inspection of material returned revealed functional damage to i2 external printer serial cable assembly in the form of multiple internal wires from the flat modular cable broken off from connector d-sub housing receptacle.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.A test i2 external printer serial cable assembly was used for performance testing and the unit passed printer test step of diagnostic test.The review determined that no non-conformances were identified that are related to the reported event.

• 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: bob fryc ; one st. jude medical drive; st. paul, MN 55117 ; 6517565400
• MDR Report Key: 17628971
• Report Number: 3004936110-2023-00917
• Device Sequence Number: 6473893
• Product Code: MOM
• UDI-Device Identifier: 05415067029331
• UDI-Public: 05415067029331
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2023

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: Other
• Device Model Number: CM3000
• Device Lot Number: 7874141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• 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 Age: 61 YR
• Patient Sex: Unknown