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 Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)

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

Event Date 03/01/2022

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 (b)(4).Due to character limitations the complete e1(event site) northern light eastern maine med ct.

Event Description

It was reported that during service repair the cardiosave intra-aortic balloon pump (iabp) unit had a defective scroll compressor out of the box.There was no patient involvement.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the cardiosave intra-aortic balloon pump (iabp) unit and replaced the scroll compressor, mufflers and cardiosave pm schedule b screw kit.The fse performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.The removed scroll compressor was returned to national repair center (nrc) for evaluation.The nrc inspected the wire harness on the compressor, scroll and observed a damaged connector.The nrc verified the failure of a faulty connector.The compressor harness failed testing.Retaining the compressor in the nrc per procedure.

Event Description

It was reported that during service repair the cardiosave intra-aortic balloon pump (iabp) unit had a defective scroll compressor out of the box and damaged cable in compressor wire harness.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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 16264439
• MDR Text Key: 308763475
• Report Number: 2249723-2023-00704
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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: 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
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1