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

Model Number	CM3000
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One cardiomems hospital electronics system was received for evaluation.Visual inspection of returned material revealed functional damage to the global system for mobile communications (gsm) antenna resulting in exposed circuitry/wires.Damage to the gsm antenna came in the form of the subminiature version a (sma) connector portion broken off from the rest of the component.Only the broken off sma connector portion of the gsm antenna was returned.Functional damage was also found on the external printer serial cable assembly in the form of the connector d-sub housing receptacle broken off from the rest of the component, resulting in exposed circuitry/wires.Only the broken off connector d-sub housing receptacle of the printer serial cable was returned.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, in which the global system for mobile communications (gsm) antenna and printer serial cable assembly were found to be broken with exposed circuitry/wires.The hospital system was replaced and there were no adverse consequences reported, and no patient involved.

• 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: todd mitchell ; 14900 minnetonka industrial road; minnetonka, MN 55345 ; 6517565400
• MDR Report Key: 23817692
• Report Number: 3004936110-2025-06597
• Device Sequence Number: 21348848
• Product Code: MOM
• UDI-Device Identifier: 05415067029331
• UDI-Public: (01)05415067029331(10)7148153
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 12/16/2025

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: 7148153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2019
• 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