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 Problems Defective Alarm (1014); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2022

Event Type  malfunction  

Event Description

It was reported by the caller the cardiosave intra-aortic balloon pump (iabp) was alarming while plugged in and turns off.There was no patient involvement.

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

At this time, the customer has not requested getinge to evaluate the iabp.Additional information was requested from the customer with regard to the repair and status of the iabp, and no repair information nor status of the iabp has been received; however, a getinge field service engineer (fse) was dispatched to the customer's site to performed a schedule preventative maintenance (pm) and completed the pm with all calibrations, functional and safety checks to meet factory specifications.Unit passed all calibrations, functional and safety test per factory specifications.Completed repair with all functional and safety tests per manufacturer specifications." h3 other text : device not returned.

• 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: 14875715
• MDR Text Key: 302937869
• Report Number: 2249723-2022-01539
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1