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

Model Number	N/A
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11067125
• Report Number: 2249723-2020-02219
• Device Sequence Number: 2691679
• Product Code: DSP
• UDI-Device Identifier: 10607567111957
• UDI-Public: 10607567111957
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1