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

Model Number N/A

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to investigate the reported issue.The stm replaced the front end board, to solve the problem.Performed all functional and safety checks to meet factory specifications.The iabp returned to the customer and cleared for clinical use.

Event Description

It was reported that before use, the ao pressure was not working in the cardiosave intra-aortic balloon pump (iabp).There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h6 (type of investigation), h10, h11.Corrected fields: e3, h3.

Event Description

It was reported that before use, the ao pressure was not working in the cardiosave intra-aortic balloon pump (iabp).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: 11348493
• MDR Text Key: 232595711
• Report Number: 2249723-2021-00331
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1