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

Model Number	0998-00-3013-53
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
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 before use, the cs100 intra-aortic balloon pump (iabp) unit won't charge above 50%.Left unit on on charger overnight.There was no patient involvement reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional initial reporter name is (b)(6).Fields d1, d4 of the emdr is for original iabp cs100; however this iabp was upgraded to a cs300 intra-aortic balloon pump.Updated fields: b4,d8, d9, g3, g6, h2,h3, h6(investigation findings, type of investigation, investigation conclusions), h11 , e3 , e1 ( event site address , initial reporter , event site email , event site telephone ).A getinge field service engineer (fse) was dispatched to evaluate the unit.Fse was not able to reproduce the issue the customer experienced.Fse removed and replaced the batteries (d146-00-0039) as a preventative measure as the customer stated that battery issues have been a problem for them.Verified the units battery fully charged.Unit passed all functional and safety tests per factory specifications.Unit returned to customer and cleared for clinical use.Corrected field : b1.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 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: 23756441
• Report Number: 2249723-2025-0005005
• Device Sequence Number: 6023869
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: (01)10607567107394
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 04/23/2026
• 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: NA.
• Patient Sex: Unknown