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	Mechanical Problem (1384); Failure to Read Input Signal (1581); Battery Problem (2885); Calibration Problem (2890)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation in e1, full event site name is (b)(6) hospital.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 displaying an error message "maintenance required, code 5, no trigger signal, battery maintenance required.Equipment did not recognize battery charge.
Additional Manufacturer Narrative
Updated fields - b4, b5, b6, b7, d9, d10, g1, g3, g6, h2, h3, h6(health effect ¿ clinical code, type of investigation, investigation findings, investigation conclusion, health effect ¿ impact codes), h11.Corrected fields - h6(medical device ¿ problem code).A getinge field service engineer (fse) observed the device and a battery test was performed and the equipment was left cycling for more than 2 hours and it showed no more defects as shown in the attached photos.Equipment tested and released for use.
Event or Problem Description
It was reported that cs100 intra-aortic balloon pump (iabp) was displaying an error message "maintenance required code 5, no trigger signal, battery maintenance required".Equipment did not recognize battery charge.Issue was found during routine check-up and there was no patient involvement.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.Corrected fields - e1(event site telephone), h6 (medical device ¿ problem code).
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: 22344436
• Report Number: 2249723-2025-0002749
• Device Sequence Number: 4901527
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2025

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: Health Professional
• Device Model Number: 0998-00-3013-69
• Device Catalogue Number: 0998-00-3013-69
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 09/29/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 09/12/2025; 09/29/2025
• 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
• Patient Sex: Unknown