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

Model Number N/A

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A supplemental report will be submitted when additional information is made available.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) rental was shipped to the customer where it was discovered that the console would not release from the cart.Service territory manager (stm) alix robinson verified the issue at the agiliti health cleveland site.During the evaluation the stm also observed that the ac line cord is also not retracting.The iabp will be shipped to the getinge national repair center for evaluation.There was no patient involvement and no adverse event reported.

Manufacturer Narrative

The cardiosave iabp was sent to the national repair center (nrc) for further evaluation and repairs; however, since there was an extensive chassis and frame damage, most likely sustained from cardiosave being dropped, the cardiosave iabp has been deemed unrepairable and will be taken out of clinical use permanently.Product is deemed not repairable and is not safe for patient use.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) rental was shipped to the customer where it was discovered that the console would not release from the cart.Service territory manager (stm) alix robinson verified the issue at the agiliti health cleveland site.During the evaluation the stm also observed that the ac line cord is also not retracting.The iabp will be shipped to the getinge national repair center for evaluation.There was no patient involvement and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID TYPE PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8898933
• MDR Text Key: 186761453
• Report Number: 2249723-2019-01301
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• 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
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1