MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-69
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation in e1, (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that cs100 intra-aortic balloon pump (iabp) was cleaned internally and externally and left to run for more than 4 hours and was approved.There was no injury reported.
Event or Problem Description
It was reported that getinge fse noticed, cs100 intra-aortic balloon pump (iabp) had shutdown by itself.There was no patient involvement.
Additional Manufacturer Narrative
E1 initial reporter name and email address provided in initial emdr is incorrect.The issue was found by getinge fse.The name and email of the getinge fse is unknown at the moment.Updated fields - b3, b4, b5, b6, b7, d5, d9, d10, e1, g2, g3, g6, h2, h3, h6 (health effect ¿impact codes), h11.A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Due to character limitation in e1, full initial reporter name is (b)(6).Updated fields - b4, e1 (initial reporter name and email), g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusion), h11.Corrected fields - g2.A getinge field service engineer (fse) states, the equipment was cleaned internally and externally and left to run for more than 4 hours and was approved.The equipment was released for use.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h6, h11.Corrected fields: g2 (report source).
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 110V
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 22662215
• Report Number: 2249723-2025-0003238
• Device Sequence Number: 18044243
• Product Code: DSP
• UDI-Device Identifier: 10607567107769
• UDI-Public: (01)10607567107769
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/07/2025

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: 0998-00-3013-69
• Device Catalogue Number: 0998-00-3013-69
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 09/11/2025; 11/07/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/04/2025; 09/23/2025; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; UNKNOWN.
• Patient Sex: Unknown