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

Model Number N/A

Device Problem Gas Output Problem (1266)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A getinge field service engineer (fse) evaluated the iabp, and was unable to reproduce the reported issue.However, in reviewing the alarm logs, the fse verified 2 "auto fill failure", and 2 "gas gain in iab circuit." the fse determined that the helium tank was low and replaced it with a customer issued part.The fse concluded that low helium in the tank could likely contribute to an autofill failure as a result of insufficient inflation in the balloon, and thereby causing a gas gain/loss in the circuit.The fse performed a function test of the unit without any issues.The fse then successfully performed a full preventative maintenance (pm) service, and performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.

Event Description

It was reported that prior to use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a "gain error" issue.However, there was no patient involvement, and no adverse event reported.

Event Description

It was reported that prior to use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a "gain error" issue.However, there was no patient involvement, and no adverse event 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: 10898150
• MDR Text Key: 218252544
• Report Number: 2249723-2020-02006
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1