MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW FIBEROPTIX IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IAB-05830-LWS

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2022

Event Type  malfunction  

Event Description

Not sure of the events, but the device was mentioned to have not "worked".Plugged into the pump, but the device would not work.

• Brand Name: ARROW FIBEROPTIX IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 15462251
• MDR Text Key: 300355667
• Report Number: 15462251
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2022,09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IAB-05830-LWS
• Device Lot Number: 18F21K0087
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1