MAUDE Adverse Event Report: ABBOTT MEDICAL CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM; System, hemodynamic, implantable

Model Number	CM3000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One cardiomems i2 hospital electronics system was received for investigation.During investigation functional damage to the i2 external printer serial cable assembly was found in the form of internal wires of the rj12 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.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 exposed wires on the i2 printer serial cable assembly.

• Brand Name: CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM
• Common Device Name: System, hemodynamic, implantable
• Manufacturer (Section D): ABBOTT MEDICAL; 387 technology circle nw suite 500; atlanta GA 30313
• Manufacturer (Section G): ABBOTT MEDICAL; 387 technology circle nw suite 500; atlanta GA 30313
• Manufacturer Contact: fredric gold ; 14900 minnetonka industrial road; minnetonka, MN 55345 ; 6517565400
• MDR Report Key: 24118368
• Report Number: 3004936110-2026-00134
• Device Sequence Number: 20330350
• Product Code: MOM
• UDI-Device Identifier: 05415067029331
• UDI-Public: (01)05415067029331(10)7474705
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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 Catalogue Number: CM3000
• Device Lot Number: 7474705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2020
• 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