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

Model Number N/A

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp and confirmed the issue on site.The fse found the leak in the back of the unit where the o-ring was broken and replaced it.Subsequently, the fse completed scheduled preventative maintenance (pm) and completed all safety, functionality, and calibration checks.All tests passed to factory specifications and the iabp unit was cleared for clinical use and released to the customer.

Event Description

It was reported that during an internal training performed by customer, the cardiosave rescue intra aortic balloon pump (iabp) experienced a helium leak.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during an internal training performed by customer, the cardiosave rescue intra aortic balloon pump (iabp) experienced a helium leak.There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE RESCUE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11382898
• MDR Text Key: 233760417
• Report Number: 2249723-2021-00457
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: 10607567108407
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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: 0998-00-0800-83
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1