MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the unit and observed the reported issue.The fse resolved the issue by replacing both batteries that were customer purchased parts and allowed the unit to charge for 48 hours.The unit was under observation, thereafter.Further, the fse performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.

Event Description

It was reported that during a routine check, the battery module of the cs100 intra-aortic balloon pump (iabp) was found to require replacement.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during a routine check, the battery module of the cs100 intra-aortic balloon pump (iabp) was found to require replacement.There was no patient involvement, and no adverse event reported.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11378585
• MDR Text Key: 233574189
• Report Number: 2249723-2021-00399
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107745
• UDI-Public: 10607567107745
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• 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: 04/02/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-UC-3013-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 04/02/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1