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

Model Number N/A

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the unit and was able to reproduce the reported issue.The fse found that the helium leak was continuous, but not in the regulator.The fse resolved the helium leak by replacing the o-ring buna-n 1-008 n70.The fse then performed leak test, 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) had a helium leak.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.

Event Description

It was reported that during a routine check, the cardiosave intra-aortic balloon pump (iabp) had a helium leak.There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID TYPE E/F PLG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11382497
• MDR Text Key: 233750024
• Report Number: 2249723-2021-00439
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1