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

Catalog Number 0998-00-3013-53

Device Problems Leak/Splash (1354); Output below Specifications (3004); Pressure Problem (3012)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested, and we will report accordingly if it becomes available.Not returned to manufacturer.

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) had a leak in iabp circuit/low vacuum alarm.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse fully checked the iabp unit and found a problem with the blood detect tubing.The fse replaced the blood detect tubing then ran the iabp unit for one hour.No alarms were observed.Subsequently, the fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.

Event Description

It was reported that prior to use, the cs100 intra-aortic balloon pump (iabp) had a leak in iabp circuit/low vacuum alarm.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that prior to use, the cs100 intra-aortic balloon pump (iabp) had a leak in iabp circuit/low vacuum alarm.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: 11096953
• MDR Text Key: 225340755
• Report Number: 2249723-2020-02253
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: 10607567107394
• 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,Followup
• Report Date: 04/30/2021

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 Catalogue Number: 0998-00-3013-53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 02/03/2021; 04/30/2021
• Supplement Dates FDA Received: 02/26/2021; 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1