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

Model Number N/A

Device Problems Mechanical Problem (1384); Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.The getinge fse successfully tested battery 1 on slot 2 and other iabps, and the battery worked and charged without exception, thus ruling out battery 1 as a problem.The fse troubled shoot the power management board, without addressing the issue.The fse suspected the power slot board to be defective and identified a broken pin on the connector to the back plane board.The power slot interface board was replaced, and battery 1 successfully ran the iabp.The fse completed pm and performed all calibration, functional and safety tests on iabp, which passed.The iabp was returned to customer and cleared for clinical use.

Event Description

It was reported that during a preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) shutdown while running on battery slot 1.There was no patient involvement, and there was no adverse event reported.

• Brand Name: CARDIOSAVE
• 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: 7791402
• MDR Text Key: 117446242
• Report Number: 2249723-2018-01414
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• 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
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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