MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0604

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

Complete event site postal code: (b)(6).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.Complaint record id # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated an autofill failure alarm and pumping failed.The balloon was replaced to continue therapy.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated an autofill failure alarm and pumping failed.The balloon was replaced to continue therapy.There was no reported injury to the patient.

Manufacturer Narrative

Updated sections: b4, d4, e1, g4, g7, h2, h6, h10.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.Complaint record #: (b)(4).

• Brand Name: TRANS-RAY PLUS 7.5 FR. 35CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9476520
• MDR Text Key: 189095571
• Report Number: 2248146-2019-00933
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2022
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000101468
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1