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

Model Number N/A

Device Problems Failure to Charge (1085); Device Sensing Problem (2917)

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2018

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 getinge standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and adjusted the optic switch.The fse performed an autofill and let machine pump to ensure proper function.The iabp passed all testing to factory specifications and was cleared for clinical use.

Event Description

It was reported that the optic switch of the cs300 intra-aortic balloon pump (iabp) needed adjusting.The batteries were not charging and the cart was not recognizing that the unit was plugged into it.This event occurred prior to use on a patient.There was no patient involvement, thus no adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and determined that the cart was not recognizing that the unit was plugged into it; therefore, the batteries were not charging.The fse adjusted the optic switch, performed an autofill and let machine pump to ensure proper function.The fse completed a preventative maintenance (pm) with full calibration, functional testing and safety checks to factory specifications.The iabp passed all testing to factory specifications and was cleared for clinical use.

Event Description

It was reported that the optic switch of the cs300 intra-aortic balloon pump (iabp) needed to be adjusted.This event occurred prior to use on a patient.There was no patient involvement, thus 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: 7769019
• MDR Text Key: 116874367
• Report Number: 2249723-2018-01350
• 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,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• 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
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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