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

Catalog Number	0998-UC-3013-45
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has not requested getinge to evaluate the iabp in connection with this event.The equipment department engineer repaired the power supply and wiring on site and there was no problem.The machine turned on normally.The machine prompted that the battery needed maintenance.After the battery maintenance was performed, the message no longer appeared.The previous automatic shutdown may be caused by a loose power cord.The iabp unit was cleared for clinical use.(b)(6).
Event or Problem Description
It was reported that before use the cs100 intra-aortic balloon pump (iabp) automatically shut down after the interventional catheterization room nurse turned it on and could not be used.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, g4, g7, h2, h6(evaluation method codes), h10.
Event or Problem Description
It was reported that before use the cs100 intra-aortic balloon pump (iabp) automatically shut down after the interventional catheterization room nurse turned it on and could not be used.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: 10592484
• Report Number: 2249723-2020-01571
• Device Sequence Number: 3985381
• 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,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: Health Professional
• Device Catalogue Number: 0998-UC-3013-45
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1