MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. CARTO 3 PATCH CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE, PATCH CABLE

Lot Number 78183

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2015

Event Type  malfunction  

Event Description

There were three separate issues with this machine.There was a warning on the carto 3 on the patches and a sensor error.No temperature being read, switched out ablation catheter.Ablation data not being crossed over to carto ge cardiolab.

• Brand Name: CARTO 3 PATCH CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE, PATCH CABLE
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 15715 arrow highway; irwindale CA 91706
• MDR Report Key: 5337769
• MDR Text Key: 34759072
• Report Number: 5337769
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2015

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?: No
• Device Operator: Physician
• Device Lot Number: 78183
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 103