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

Model Number	0998-00-3013-65
Medical Device Problem Codes	Failure to Charge (1085); Charging Problem (2892)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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) cannot be charged.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.Corrected field: h6 investigation findings, health effect ¿ impact codes, investigation conclusion.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) cannot be charged.No harm.
Additional Manufacturer Narrative
Updated fields - b4, d8, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected field: d1 brand name, g4.Due to character limit in e1 event site address is (b)(6).A getinge field service engineer (fse) found the device cannot be charged.Explained to the hospital person in charge that a malfunction of the battery or power supply is suspected.Reported that the service has ended in japan and repairs cannot be carried out and the response was terminated.The device will be discarded and replaced.
Additional Manufacturer Narrative
A getinge field service engineer (fse) found the device cannot be charged.Explained to the hospital person in charge that a malfunction of the battery or power supply is suspected.Reported that the service has ended in japan and repairs cannot be carried out and the response was terminated.The device will be discarded and replaced.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 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: 21190446
• Report Number: 2249723-2025-0000276
• Device Sequence Number: 3378466
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: (01)10607567107684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/25/2026

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: 0998-00-3013-65
• Device Catalogue Number: 0998-00-3013-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/01/2025
• Supplement Date Received by Manufacturer: 10/23/2025; 10/31/2025; 02/25/2026
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 10/30/2025; 10/31/2025; 02/24/2026
• 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: UNKNOWN.
• Patient Sex: Unknown