MAUDE Adverse Event Report: ABBOTT MEDICAL. CMEMS PRINTER SERIAL CABLE; SYSTEM, HEMODYNAMIC, IMPLANTABLE

Model Number	CM3011
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One cardiomems hospital electronic system was received for evaluation.Visual inspection verified the printer serial cable had exposed wires.Unit was powered on multiple times without any issues.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 of the hospital electronic system having a functionally damaged gsm antenna.Also, the unit¿s printer test step failure in initial diagnostic test concluded to be a damaged i2 external printer serial cable assembly with exposed wires.The hospital electronic system was replaced.

• Brand Name: CMEMS PRINTER SERIAL CABLE
• 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: 21633266
• Report Number: 3004936110-2025-00495
• Device Sequence Number: 9246170
• Product Code: MOM
• UDI-Device Identifier: 05415067029331
• UDI-Public: (01)05415067029331(10)6455256
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: Health Professional
• Device Model Number: CM3011
• Device Catalogue Number: CM3011
• Device Lot Number: 6455256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2018
• 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