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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.This report is being submitted as the result of a retrospective review conducted in capa 584165.

Event Description

It was reported that during schedule service, one of the led charge indicators for the battery (the 4th one from the bottom up) in cardiosave intra-aortic balloon pump (iabp) was defective.There was no patient involvement.

Manufacturer Narrative

A getinge field service engineer (fse) that encountered the issue, replaced the batteries.Unit passed all functional and safety test per factory specifications.The fse performed a calibration to the unit and passed all functional and safety tests per factory specifications.Iabp was returned to customer and cleared for clinical use.

Event Description

It was reported that during schedule service, one of the led charge indicators for the battery (the 4th one from the bottom up) in cardiosave intra-aortic balloon pump (iabp) was defective.Patient involved.

• 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: 16241314
• MDR Text Key: 308203708
• Report Number: 2249723-2023-00445
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

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: 02/01/2021
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.