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); Device Emits Odor (1425)

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

Event Date 07/29/2022

Event Type  malfunction  

Event Description

It was reported that during testing observed by the end user, the cardiosave intra-aortic balloon pump (iabp) unit had a burning smell.There as no patient involvement reported.

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) had a burning smell.There as no patient involvement reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.The fse tested the unit and observed a burning smell coming from cardiosave cart.During testing the fse observed that no ac led indication of power and the cart was not charging the batteries and led indication of battery charge cycle.The fse then observed that there was no bulk supply from cart power supply.So, in order to fix the issue the fse replaced the bulk power supply (0014-00-0258) which corrected the bulk cart power supply failure.Unit passed all functional and safety tests per factory specifications.The unit was then returned to customer and cleared for clinical use.The following investigation was performed by technician of the failure analysis and testing dept.(fat) wayne, nj: cf 30 jan 2023.The fat received part number 0014-00-0258 cart bulk power supply spec serial number (b)(6) with the reported complaint of a burning smell.The fat performed a visual inspection and found that the power supply had burnt components which produced the burning smell that was reported.Components were burnt by transformer x5.The burning of the components resulted in damage to the pc board.Due to this damage and the risk it poses, this part cannot be investigated any further by the fat.Retaining the board in the fat per procedure number 0002-07-d008 revision aj.

• 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: 15265411
• MDR Text Key: 298410766
• Report Number: 2249723-2022-02122
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• 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: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.