MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0575

Device Problems Failure to Calibrate (2440); Device Displays Incorrect Message (2591)

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

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) there was an "unable to calibrate iab optical sensor" alarm generated.The customer tried to calibrate once pulse pressure was adequate but it was unsuccessful.The fiber optic cable was disconnected and reconnected, but that did not resolve the problem.The central lumen was transduced.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) there was an "unable to calibrate iab optical sensor" alarm generated.The customer tried to calibrate once pulse pressure was adequate but it was unsuccessful.The fiber optic cable was disconnected and reconnected, but that did not resolve the problem.The central lumen was transduced.There was no reported injury to the patient.

Manufacturer Narrative

Additional information: device available for evaluation: [from]: yes, [to]: no.(b)(4).

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8209438
• MDR Text Key: 131918503
• Report Number: 2248146-2019-00001
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000081750
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 156