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

Model Number N/A

Device Problems Power Problem (3010); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The stm confirmed with the user that the error code appeared after failed attempts to calibrate the touchscreen.The stm noted the error auto generates if the end user has three failed touch calibrations.The stm instructed the user in the proper method of touchscreen calibration and had them perform a calibration, which was successful.The stm asked the user to restart the iabp and confirmed the error was cleared.The iabp unit was cleared for clinical use and released to the customer.(b)(6).

Event Description

It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) had a power test #6 failure.There as no patient involvement, and no adverse event reported.

Event Description

It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) had a power test #6 failure.There as 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: 10562471
• MDR Text Key: 207897174
• Report Number: 2249723-2020-01530
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• 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: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1