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

Model Number	CM3011
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 i2 cardiomems hospital electronics system was returned for investigation.Inspection of unit revealed exposed wires on the printer serial cable due to physical damage.A replacement serial printer cable was used and the unit was able to conduct successful diagnostic testing.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.The root cause of the exposed wires was isolated to physical damage due to an undetermined event.

• Brand Name: CMEMS PRINTER SERIAL CABLE
• Common Device Name: SYSTEM, HEMODYNAMIC, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; 387 technology circle nw suite 500; atlanta GA 30313
• Manufacturer (Section G): ST. JUDE MEDICAL; 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: 15975932
• Report Number: 3004936110-2022-00691
• Device Sequence Number: 5858414
• Product Code: MOM
• UDI-Device Identifier: 05415067029331
• UDI-Public: 05415067029331
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2022

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: CM3000
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• 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