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	Failure to Sense (1559)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) units doppler box is broken and the battery cover is missing.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated sections: b4, g3, g6, h2, h10, h11 corrected sections: b5, h6(health clinical & impact).
Event or Problem Description
It was reported during patient use, the cs100 intra-aortic balloon pump (iabp) unit doppler box is broken and the battery cover is missing.There was no patient harm reported.
Event or Problem Description
It was reported that before use, the cs100 intra-aortic balloon pump (iabp) unit doppler box is broken and the battery cover is missing.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields: b4, d9(device available for eval), g3, g6, h2, h3, h4, h6(investigation type, investigation findings, component codes & investigation conclusions), h10 at this time, the customer has not requested for getinge to repair the unit for the reported malfunction.The customer purchased a new doppler ultrasonic iabp assembly.The status of the iabp is unknown.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.H3 other text : evaluation not requested by complainant.
Event or Problem Description
N/a.

• 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: 16178747
• Report Number: 2249723-2023-00229
• Device Sequence Number: 11369843
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/31/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/18/2023; 03/29/2023; 04/12/2023; 07/31/2023
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 02/06/2023; 03/30/2023; 04/24/2023; 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown