MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Circuit Failure (1089); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and was unable to reproduce the reported "gas loss error." however, in evaluating the unit, the fse discovered that the unit failed pim leak test after cycling the unit at 100 bpm with a test set up.As such, the fse replaced the safety and tidal disks, and re-tested the unit five times with passing results.The fse then performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.(b)(6).

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit had a gas loss in the iab circuit, and was swapped out.No patient harm, serious injury or adverse event was reported.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit had a gas loss in the iab circuit, and was swapped out.No patient harm, serious injury or adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10805472
• MDR Text Key: 218956642
• Report Number: 2249723-2020-01852
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1