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

Model Number N/A

Device Problem Unexpected Shutdown (4019)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

At this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event.A third party distributor performed service repairs in relation to this reported event.Additional information has been requested, and we will report accordingly if it becomes available.(b)(6).

Event Description

It was reported by the distributor that prior to use, the cs100 intra-aortic balloon pump (iabp) unexpectedly shutdown after the unit was turned on for less than one minute.It was also reported that the customer checked to ensure that the power supply was connected and attempted to restart the unit.However, the reported issue persisted and the customer switched to another iabp unit.There was no patient involvement, and no adverse event reported.

Event Description

It was reported by the distributor that prior to use, the cs100 intra-aortic balloon pump (iabp) unexpectedly shutdown after the unit was turned on for less than one minute.It was also reported that the customer checked to ensure that the power supply was connected and attempted to restart the unit.However, the reported issue persisted and the customer switched to another iabp unit.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: 11067125
• MDR Text Key: 224352762
• Report Number: 2249723-2020-02219
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567111957
• UDI-Public: 10607567111957
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

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 Model Number: N/A
• Device Catalogue Number: 0998-00-3013-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1