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

Model Number	CM3100
Medical Device Problem Codes	Break (1069); Loose or Intermittent Connection (1371); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of an event observed during analysis confirming exposed wires on the internal cable connecting the wand port to the telemetry printed circuit board (pcb).The hospital electronic unit was replaced and there were no patients involved.
Additional Manufacturer Narrative
One hospital system 2.0, us was received for evaluation.Visual inspection verified the unit touchscreen display and chassis were free of physical damage.The wand port was loose and extruding from the device chassis.The device was opened up, and it was revealed that the internal wand port fastener had come completely loose and that multiple wires within the cable connecting the wand port to the telemetry pcb had become detached.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.

• Brand Name: CARDIOMEMS¿ HOSPITAL 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: 24687416
• Report Number: 3004936110-2026-00553
• Device Sequence Number: 10014738
• Product Code: MOM
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/25/2026

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: CM3100
• Device Catalogue Number: CM3100
• Device Lot Number: 8577178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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