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

Model Number N/A

Device Problem Gas/Air Leak (2946)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp, but was unable to reproduce the reported gas leak.The fse performed full calibration, all functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.However, additional information is being requested with regard to the reported event repair of the iabp unit.A supplemental report will be submitted when this information is provided to us.(b)(6).

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had a gas leak.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

The iabp evaluation has been completed, no additional repair information is pending as the unit has been returned to the customer and cleared for clinical use.

Event Description

It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) had a gas leak.There was no harm or injury to patient and no adverse event was reported.

Event Description

It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) had a gas leak.There was no harm or injury to patient and no adverse event was reported.

Event Description

It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) had a gas leak.There was no harm or injury to patient 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 CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11229891
• MDR Text Key: 228700979
• Report Number: 2249723-2021-00140
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• 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,Followup,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 01/27/2021; 04/02/2021; 05/19/2021
• Supplement Dates FDA Received: 02/22/2021; 04/23/2021; 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1