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

Model Number N/A

Device Problem Computer Operating System Problem (2898)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2018

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. During a preventive maintenance (pm), the getinge field service engineer (fse) noticed that the coil cable nylon retainer to be broken, allowing the coil cable and backplane cable to get damaged and lose connection causing the iabp to turn off and reboot. The fse disassembled the unit removed and replaced coiled cable, backplane cable, seal gasket and nylon cable tie and re-assembled the unit and performed a full pm with calibrations and all testing per manufacture specifications cleared for clinical use. (b)(6).

Event Description

It was reported during a preventive maintenance (pm) by a getinge field service engineer (fse) that the cardiosave intra-aortic balloon pump failed to boot up. There was no patient involvement, therefore no adverse event was 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: 7582724
• MDR Text Key: 110859299
• Report Number: 2249723-2018-00970
• 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

• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/08/2018
• 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
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse