MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. - CARDIOMEMS CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM

Model Number	CM3000
Medical Device Problem Codes	Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the hospital electronics system began to spark when being plugging in and black smoke started coming out.Customer was not harmed.Issue was resolved by replacing the unit.

• Brand Name: CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM
• Common Device Name: CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. - CARDIOMEMS; 387 technology circle nw suite 500; atlanta GA 30313
• MDR Report Key: 8529454
• Report Number: 3004936110-2019-00207
• Device Sequence Number: 19522597
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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 Catalogue Number: CM3000
• Device Lot Number: 6455253
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other