MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3013-53
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cs300 intra-aortic balloon pump (iabp) received a "disconnected" error on a cs300 but states that "all wires and tubes were connected." further reported that patient was not moving and helium tank level was acceptable and cs300 goes into standby automatically during "iab disconnected" alarm.There was no harm reported to patient.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b3, b4, d4 (serial no.), d8, d9, e1 (event site telephone), g3, g6, h2, h11.Corrected fields: d4 (version, catalouge).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, d4 (udi), g3, g6, h2, h3, h6 (investigation findings , investigation conclusion, type of investigation), h11 corrected fields: b5, d1 (brand name), g3 correct date received by mfg date in follow up 1 emdr (2249723-2025-0001947 ) was (b)(6) 2025, g4 however this iabp was upgraded to a cs300 intra-aortic balloon pump, english, 110v catalog #0998-00-3023-53 udi # (b)(4), which was reported by the customer a getinge field service engineer (fse) could not duplicate the reported issue as the device serviced by the customer.All functional and safety checks are meet to factory specifications performed and returned to use.
Event or Problem Description
It was reported that cs300 intra-aortic balloon pump (iabp) received a "disconnected" error on a cs300 but states that "all wires and tubes were connected." further reported that patient was not moving and helium tank level was acceptable and cs300 goes into standby automatically during "iab disconnected" alarm.There was no harm reported to patient.However this iabp was upgraded to a cs300 intra-aortic balloon pump, english, 110v catalog # 998-00-3013-53 udi #(b)(4), which was reported by the customer.
Additional Manufacturer Narrative
Updated fields: corrected fields: d1, d4 (model, catalog, udi), e2.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM
• 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: 21907536
• Report Number: 2249723-2025-0001947
• Device Sequence Number: 8728505
• Product Code: DSP
• UDI-Device Identifier: 10607567107745
• UDI-Public: (01)10607567107745
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/02/2025

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-UC-3013-53
• Device Catalogue Number: 0998-UC-3013-53
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/28/2025; 06/20/2025; 06/25/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/02/2025; 06/24/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown