MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-68
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions initial reporter address: hospital (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that, the cs100 intra-aortic balloon pump (iabp) unit was damaged during transport.There was no patient involvement.
Event or Problem Description
It was reported that, the cs100 intra-aortic balloon pump (iabp) unit was damaged during transport between mainland portugal and the hospital in ponta delgada in the azores.There was no patient involvement.
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the unit for the reported malfunction.The fse stated that the main broken part ,chassis is no longer supplied from the factory as the cs100 has been discontinued.The unit will be taken out of service.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 220V
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 16178837
• Report Number: 2249723-2023-00233
• Device Sequence Number: 2633799
• Product Code: DSP
• UDI-Device Identifier: 10607567107691
• UDI-Public: 10607567107691
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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 Model Number: 0998-00-3013-68
• Device Catalogue Number: 0998-00-3013-68
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown