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

Model Number N/A

Device Problems Leak/Splash (1354); Computer Operating System Problem (2898)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2018

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.Upon further inspection by the getinge stm, the only fluid intrusion that was found was on top of the printer recorder which caused electrical damage to the recorder.To resolve the issue, the stm replaced the printer and the recorder and the iabp was able to print.The stm then completed the pm and performed all safety, electrical and functional tests to meet factory specifications.The initial reporter named is a getinge employee who has different contact details from that of the event site.Please refer to the following email and phone number: (b)(6).

Event Description

During preventive maintenance (pm) service of cardiosave intra-aortic balloon pump (iabp), the getinge service territory manager (stm) discovered the recorder failed to print.Additionally, the stm observed evidence of a saline spill on the front of the iabp.There was no patient involvement, thus 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: 8111916
• MDR Text Key: 128888440
• Report Number: 2249723-2018-02074
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• 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: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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