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

Model Number N/A

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2018

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.Getinge service was not requested in connection with this even.However, the facility's biomedical engineer determined that the reported issue was a user error.The iabp had been disengaged from the cart causing the issue.The biomed reseated the iabp in the cart and the unit was able to run off a/c power.The iabp was released back to clinical use.

Event Description

It was reported that during use the cardiosave intra-aortic balloon pump (iabp) was running on the batteries even though it was plugged in and was showing 25 minutes remaining.The iabp was plugged into another outlet without change, so it was decided that the iabp would be replaced by another iabp.However, by the time the second iabp arrived, the original had powered off.The second iabp was initially running as hybrid while it was plugged in.The technician checked if the unit was disengaged as a rescue unit to which he was able to pull the rescue unit out without unlocking from the cart.The iabp was pushed back into the cart and then it was turned back on after waiting five (5) minutes.It then showed the unit as a hybrid and the power was coming into the unit.There was no patient harm and 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: 8052555
• MDR Text Key: 128260811
• Report Number: 2249723-2018-01938
• 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
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: No
• 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?: No
• Device Age: YR
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2017
• 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
• Patient Age: 77 YR
• Patient Weight: 65