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

Model Number N/A

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and found that the pressure was very slow to calibrate and was unable to adjust pressure above 365.The fse troubleshooted the unit and identified that the scroll compressor was defective.As such, the fse resolved the issue by replacing the scroll compressor and filters.The fse then successfully performed drive calibration, as well as pm with full calibration, all functional and safety checks to meet factory specifications.Moreover, as part of pm protocol, the fse replaced the expired main batteries and critical alarm battery.The iabp was then released to the customer and cleared for clinical service.(b)(6).

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the pressure regulator calibration failed.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the pressure regulator calibration failed.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 07430
• MDR Report Key: 11382855
• MDR Text Key: 233752454
• Report Number: 2249723-2021-00453
• 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
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1