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

Model Number N/A

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2018

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 stm that discovered the issue replaced the touchscreen due to non-functional sections even after multiple calibrations.The stm then tested the new touchscreen, verified iabp calibration and ensured that all functional and safety tests were passed within factory specifications.The iabp was returned to the customer and cleared for clinical use.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 as contact information for the initial reporter: (b)(6).

Event Description

A getinge service territory manager (stm) reported that during a check of the cardiosave intra-aortic balloon pump (iabp), he found that the touchscreen function would come and go even after calibration.There was no patient involvement and 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: 7812956
• MDR Text Key: 118395069
• Report Number: 2249723-2018-01473
• 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: 08/24/2018

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: 08/03/2018
• Initial Date FDA Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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