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

Model Number 0998-00-0800-53

Device Problems Infusion or Flow Problem (2964); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated and was able to reproduce the reported issue.The fse troubleshooted the unit and found a compressor related issue.Additionally, the fse reported to have found logs related to vacuum alarms.The fse resolved the reported issue by replacing the scroll compressor, and then performed 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 cardiosave intra-aortic balloon pump (iabp) alarmed iab catheter restrictions.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.

Event Description

It was reported that cardiosave intra-aortic balloon pump (iabp) alarmed iab catheter restrictions.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event 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
• MDR Report Key: 11503495
• MDR Text Key: 240416668
• Report Number: 2249723-2021-00538
• 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
• Report Date: 06/03/2021

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: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 04/29/2021; 06/03/2021
• Supplement Dates FDA Received: 04/29/2021; 06/08/2021
• Patient Sequence Number: 1