MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. ESOPHASTAR; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number F8ENNNNHSB

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2021

Event Type  malfunction  

Event Description

Sensor error @ tip of catheter.Catheter replaced, sensor error resolved.No harm to pt.

• Brand Name: ESOPHASTAR
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 5110 commerce rd.; baldwin park CA 91706
• MDR Report Key: 12173278
• MDR Text Key: 261721622
• Report Number: 12173278
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F8ENNNNHSB
• Device Catalogue Number: F8ENNNNHSB
• Device Lot Number: 30558832L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Weight: 100