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

Model Number	CM3000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During the cardiomems implant procedure the hospital electronics unit displayed an error 5 message indicating the time of day clock for the system was off.The user was unable to log in to the unit due to the error and could not proceed with the case so the procedure was abandoned.There were no adverse consequences to the patient.There is no information to indicate that this error 5 was related to the incorrect speed setting.
Additional Manufacturer Narrative
One (b)(6) hospital electronics system was received for evaluation.Error # 5 was not generated when either the new implant or follow-up pressure measurement icons were selected on the pressure measurement selection screen.Error # 5 was not observed recorded in message logs of unit¿s terminal application or from review of unit¿s logs on the cardiomemshf back end website.The unit displayed a warning # 5 after finishing the boot up process and would not accept login credentials.Warning # 5 involves a time discrepancy recorded by the software.The unit¿s initial date and time could not be observed with its front-end interface because of login credentials not being accepted.The date and time were instead observed by booting the unit up with a service thumb drive installed and accessing the date/ time setup application.Unit¿s date and time were observed to be off by 25 years 7 months 11 days and 16 hours 36 minutes respectively.The root cause of unit displaying warning # 5 was concluded to be due to a depleted coin lithium battery on the printed circuit board.Depletion of the coin lithium battery caused the unit not to keep correct time.The unit¿s incorrect date and time being outside the requisite range associated with the current credentials to access the server results in inability to login to the hospital electronics system software.The product issue encountered in the field was determined to be warning # 5 that was mistakenly categorized as a complaint involving error # 5.A review of the device history record was performed and ruled out the possibility of a manufacturing related issue causing or contributing to the reported complaint issue, as no non-conformance related to the reported issue was found in the batch records reviewed.

• 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: melissa wappel ; 14900 minnetonka industrial road; minnetonka, MN 55345 ; 6517565400
• MDR Report Key: 18666877
• Report Number: 3004936110-2024-00188
• Device Sequence Number: 17943330
• Product Code: MOM
• UDI-Device Identifier: 05414734509244
• UDI-Public: 05414734509244
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CM3000
• Device Lot Number: 5110528
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown