MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 07/24/2020

Event Type  Death  

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.Complaint record id # (b)(4).

Event Description

It was reported during intra-aortic balloon(iab) therapy, the console generated maintenance code 35 may be required alarm.After the machine alarmed, the customer replaced the standby machine.The patient's condition was stable for a while, and subsequently patient eventually died, the cause is unknown.There was no reported malfunction on the intra-aortic balloon(iab).A separate report will be submitted for the iabp involved.

Event Description

It was reported during intra-aortic balloon(iab) therapy, the console generated maintenance code 35 may be required alarm.After the machine alarmed, the customer replaced the standby machine.The patient's condition was stable for a while, and subsequently patient eventually died, the cause is unknown.There was no reported malfunction on the intra-aortic balloon(iab).A separate report will be submitted for the iabp involved.

Manufacturer Narrative

Additional information: udi number: (b)(4).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.Reference complaint #(b)(4).

• Brand Name: LINEAR 7.5 FR. 34CC 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: 10385229
• MDR Text Key: 202206431
• Report Number: 2248146-2020-00417
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CS100; CS100; CS100
• Patient Outcome(s): Death
• Patient Age: 78 YR