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

Model Number 0998-00-0800-53

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 10/25/2023

Event Type  malfunction  

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit had a system temp alarm.

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during use, the cardiosave intra-aortic balloon pump (iabp) unit had a system temp alarm.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d9(device available for eval), g3, g6, h2, h3, h4, h6(investigation type, investigation findings & investigation conclusions), h10.A getinge field service engineer (fse) was dispatched to evaluate this unit.After reviewing event and fault logs, fse did not find any temperature errors or faults.Fse connected the system trainer and could not duplicate any alarms.Fse performed a pm, full calibration, and tested the unit.The product passed all functional/safety testing.Returned the unit to the customer.

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 18064922
• MDR Text Key: 327276317
• Report Number: 2249723-2023-04715
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1