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 Problem Component Incompatible (1108)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: (10/213) during a preventative maintenance (pm) service, the getinge field service engineer (fse) discovered the unit failed the drive manifold section of the all manifold tests.Initially, the drive manifold was replaced and the system was retested, but the all manifold tests still failed.After further troubleshooting, the scroll compressor was determined to be faulty, to fix the issue it was replaced, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).

Event Description

It was reported that during scheduled pm performed by a getinge field service engineer (fse), the unit failed the drive manifold section of the all manifold tests.There was no patient involvement.

Manufacturer Narrative

Updated fields: b4,e1(site country),g3,g6,h2,h4,h6(type of investigation, investigation findings, component codes, investigation conclusions), h10.It was reported that during scheduled pm performed by a getinge field service engineer (fse), the unit failed the drive manifold section of the all manifold tests.There was no patient involvement or adverse event reported.To resolve the issue a getinge fse replaced the drive manifold and scroll compressor.After the repair, the unit passed all functional and safety tests per factory specifcations.It has been returned to the customer and cleared for clinical use.

Event Description

N/a.

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: dorota wolpiuk ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12258210
• MDR Text Key: 264462543
• Report Number: 2249723-2021-01663
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• 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
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1