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

Model Number N/A

Device Problems Failure to Power Up (1476); Communication or Transmission Problem (2896); Computer Operating System Problem (2898)

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

Event Date 07/05/2018

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.Evaluation conclusion codes: cause traced to component failure, (b)(4).A getinge field service engineer (fse) was dispatched to evaluated the iabp unit.The fse moved the coiled cable and the iabp had a fatal alarm and shut down.The fse discovered on the corner of the monitor was damaged.The fse had to replace the damaged pinched cable from the lower to the upper display, the coiled cables, the cable tie, the cardiosave label, the inside badge, and the hinge cover.Unrelated to the complaint issue, the fse replaced the four screws on the video generator, because they were missing.After replacing the parts, the iabp unit was still did not powering up properly.To fix the issue, the fse replaced the executive processor board, and performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that during a routine check, the cardiosave intra-aortic balloon pump (iabp) would not complete boot up.The iabp has an internal communication failure.The blue circle on the screen keeps spinning.After several attempts, the iabp unit was able to power up.No patient was involved 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: 7726275
• MDR Text Key: 115470143
• Report Number: 2249723-2018-01267
• Device Sequence Number: 0
• Product Code: DSP
• 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
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 07/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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