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 Defective Component (2292)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit had a drive manifold test failure.

Manufacturer Narrative

Investigation finalized on (b)(6) 2024: a getinge field service engineer evaluated unit and found drive manifold test to fail during pm.Replaced drive manifold and compressor.Ran and passed all performance and function tests.The scroll compressor and drive manifold were received by national repair center (nrc) for further investigation.Performed visual inspection of these parts received and parts looks to be in good condition.The failure analysis and testing department could not verify the failure of failing drive manifold tests.The compressor scroll and drive manifold assy.Passed testing.The non-conformances with the returned components were not confirmed.

Event Description

It was reported that during a preventive maintenance performed by a getinge field service engineer (gfse), the cardiosave intra-aortic balloon pump (iabp) unit had a drive manifold test failure.There was no patient involvement.

• 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: 15401644
• MDR Text Key: 305489881
• Report Number: 2249723-2022-02303
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.