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

Model Number N/A

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp and was unable to reproduce the reported issue.However, based on the fault codes in the unit's logs, the fse replaced the executive processor pcb.Unrelated to said reported issue, the fse also found the fiber optic connector and p-clip were damaged and replaced same, respectively.Moreover, the fse replaced both expired lithium-ion batteries, and replaced the expired critical alarm 9v battery.After repairs were completed, the unit was left to run over night while connected to a system trainer and test balloon with no failures.The fse then performed a full calibration, 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 ambulance transport, the cardiosave intra-aortic balloon pump (iabp) unit shutdown.No patient harm, serious injury or adverse event was reported.

Event Description

It was reported that during ambulance transport, the cardiosave intra-aortic balloon pump (iabp) unit shutdown.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: 11060786
• MDR Text Key: 225339574
• Report Number: 2249723-2020-02207
• 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: 02/08/2021

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: 11/30/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1