MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.A getinge service territory manager (stm) was dispatched to investigate and confirmed the reported issue and noted that the device was fully functional except for the battery operation.The stm reviewed the log files and found no electrical failure codes and verified batteries are not showing any data in the service menu.The stm replaced the power management board and made sure the harnesses were seated properly but the iabp unit still fails in battery mode.The stm returned the next day and replaced 2nd power management board, power supply assembly, executive processor board, backplane board, and front end board, but the iabp continued to fail with no battery function.The stm then investigated further and removed the power slot interface board and discovered saline residue under the power slot interface chassis and in between the chassis and the power slot interface board at the j4 connector.The stm reinstalled all original boards and cleaned and dried the saline residue out of the bottom of chassis.The stm noted there was no signs of saline that entered through the main unit.The stm then returned the next day and replaced the power slot interface board and reassembled the device for testing, but the iabp still remains operating on ac power only.The stm consulted with the customer and had the iabp unit brought to his office for further investigation and found that the j15 was not seated correctly.The stm repositioned, reseated and secured the j15 wire harness, and tested the device.The batteries were charging and the iabp unit was able to operate on the battery.The stm tested the iabp unit for a few hours without any further failures.The stm then performed all calibration, functional and safety tests per factory specifications and the iabp was returned to the customer and cleared for clinical service.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was not recognizing the batteries, and was unable to detect the batteries in bay 1 and 2.It is unknown under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 8191631
• MDR Text Key: 131332099
• Report Number: 2249723-2018-02208
• Device Sequence Number: 1
• Product Code: DSP
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2018

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: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1