MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the unit, but was unable to reproduce the low vacuum alarm.The unit passed initial start-up sequence and performed autofill without failure.The fse reported that low vacuum and leak in iab circuit alarms were noted in the unit's logs; however, was unable to reproduce any of the aforementioned alarms.Additionally, the fse replaced the safety disk and verified proper operation of low battery alarm.The fse then performed a successful pm with full calibration, functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.(b)(6).Patient height: 177cm.

Event Description

It was reported that during use, the cs300 intra-aortic balloon pump (iabp) alarmed low vacuum, repeatedly, and then stopped pumping.It was also reported that the unit was changed for another maquet iabp unit without effecting the patient, and taken to the customer's biomedical department.No patient harm, serious injury or adverse event was reported.

Event Description

It was reported that during use, the cs300 intra-aortic balloon pump (iabp) alarmed low vacuum, repeatedly, and then stopped pumping.It was also reported that the unit was changed for another maquet iabp unit without effecting the patient, and taken to the customer's biomedical department.No patient harm, serious injury or adverse event was reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11367626
• MDR Text Key: 233256814
• Report Number: 2249723-2021-00347
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• 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: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 81