MAUDE Adverse Event Report: ST. JUDE MEDICAL 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	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is included in the error 5 advisory notice issued by abbott on 01 june 2018.The investigation codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported that the hospital electronics unit received an error 5 message, which indicates an issue related to temperature and barometric pressure.Troubleshooting the unit was able to resolve the issue.
Additional Manufacturer Narrative
The reported issue of "error 5" was confirmed.Backend verification confirmed that the error 5 issue was present on 12sep2022.The affected unit was operating on software version 1.7.1-r5 at the time of complaint.The reoccurrence of error 5 notification was due to a software issue with software version 1.7.1-r5.The error would not clear on its own, and the error was required to be manually cleared.The issue was corrected under the latest software version.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM
• 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: 15542569
• Report Number: 3004936110-2022-00515
• Device Sequence Number: 6575686
• Product Code: MOM
• UDI-Device Identifier: 05415067029331
• UDI-Public: 05415067029331
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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: CM3000
• Device Catalogue Number: CM3000
• Device Lot Number: 6268623
• Was Device Available for Evaluation?: No
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3004936110-06/01/18-001R
• Patient Sequence Number: 1
• Patient Sex: Unknown