MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM; SYSTEM, HEMODYNAMIC, IMPLANTABLE

Model Number	CM3000
Medical Device Problem Codes	Break (1069); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The power cord of the pes was frayed.The cord sparked at the area where it plugged into the power supply.The power cord and power supply were replaced.There were no adverse consequences as a result of the issue.No patient was involved.On (b)(6) 2022, the hes still sparked from the access plate at the power port following replacement of the power supply and power cord.
Additional Manufacturer Narrative
No device analysis results are available because the device was not 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.
Additional Manufacturer Narrative
One cardiomems hospital electronic system was received for evaluation.Visual inspection of material returned revealed functional damage to i2 external printer serial cable assembly in the form of an internal wire from the rj12 flat modular cable broken off from connector d-sub housing receptacle.Visual inspection of returned material also revealed missing hardware in the form of two lock washers 1 18-8 4-40 kep nuts that assemble the i2 power connector cable assembly to np i2 power bracket, as well as the i2 printer mounting strap.Loose hardware was also observed in the form of two 18-8 6-32 kep nuts and i2 printer mounting bracket that assemble the i2 printer mounting strap to i2 enclosure ¿ front plastic.No blown components, burnt areas, or any other residual effects that could have been caused by sparks were observed.No software malfunctions or anomalies were observed.A sparking sound was produced and unit prematurely shut off during manipulation of power supply connection areas.This was attributed to an electrical short occurring when the bus wire of the 3a 5-pin din connector on i2 power connector cable assembly unintentionally contacted the connector d-sub housing receptacle of a test i2 external printer serial cable assembly connected to unit.This unintentional contact was due to the din connector of printer serial cable assembly not being properly attached to np i2 power bracket because of missing hardware stated in visual evaluation.Unit remained powered on when connector d-sub housing receptacle of test printer serial cable assembly was kept away from i2 power connector cable assembly.Unit passed diagnostic test complaint of ¿the hes still sparked from the access plate at the power port¿ confirmed.The occurrence of sparks determined be due to bus wire of 3a 5-pin din connector on i2 power connector cable assembly (cs-000481) being loose and unintentionally contacting a metal surface.Root cause concluded to be rc012 loose component.Investigation results for complaint of ¿the power cord of the hes was frayed¿ were determined to be inconclusive.The returned ac power cord with ferrite was determined to be a replacement and not the original one stated to be frayed in complaint event description.This is based on the returned power cord having no observed damage and the statement in complaint event description of a replacement used in the field.

• Brand Name: CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM
• Common Device Name: SYSTEM, HEMODYNAMIC, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 387 technology circle nw suite 500; atlanta GA 30313
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 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: 14431323
• Report Number: 3004936110-2022-00248
• Device Sequence Number: 14824790
• Product Code: MOM
• UDI-Device Identifier: 05415067029331
• UDI-Public: 05415067029331
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2023

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: CM3000
• Device Catalogue Number: CM3000
• Device Lot Number: 7953487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 07/13/2022; 05/29/2023
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 07/19/2022; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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