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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restriction in e1: full event site name: (b)(6).A supplemental report will be submitted on completion of our investigation.
Event or Problem Description
It was reported that before use the glass of blood detector hose of cs100 intra aortic balloon pump(iabp) was broken.There was no patient involvement.
Event or Problem Description
It was reported by the field service engineer (fse) that during preventive maintenance (pm) the cs100 intra aortic balloon pump (iabp) had broken blood detector hose.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11 corrected field: b5, d5, e1 (initial reporter, event site email), e2, e3, e4, g2.H6 (health effect ¿ impact codes).A getinge field service engineer (fse) replaced blood detector tube to resolve the issue.All functional and safety checks performed to meet factory specifications.
Event or Problem Description
It was reported by the field service engineer (fse) that during preventive maintenance (pm) the cs100 intra aortic balloon pump (iabp) had broken blood detector hose.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.Corrected fields - b5.

• 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21444532
• Report Number: 2249723-2025-0000854
• Device Sequence Number: 18134752
• 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
• Report Date (Section B): 07/01/2025

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: 02/06/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 07/01/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 06/27/2025; 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2009
• 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.
• Patient Sex: Unknown