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 Codes	Signal Artifact/Noise (1036); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer through the emergency support program (esp) that during use, the cs100 intra-aortic balloon pump (iabp) exhibited a damped arterial waveform, loss of augmentation/support, and multiple alarms.There was patient involvement reported, and no injury or harm was reported.The customer reported that augmentation pressures had initially been in the 110s before the arterial waveform suddenly became damped and adequate support could no longer be obtained.An augmentation alarm was observed on pump 1, and the customer initiated an exchange to pump 2.Following the exchange, an "unable to update timing" alarm was observed on pump 2 (sa03479-b5).Esp personnel instructed the customer to place the console in standby, aspirate and flush the arterial pressure line using the transducer for 20-30 seconds, and restart the pump.Following these actions, the arterial waveform quality immediately improved and the alarm resolved.Troubleshooting determined that the catheter and pumps were functioning as intended and that the reported condition was not associated with a device malfunction but rather with line maintenance/user-related factors.Esp personnel reviewed line maintenance recommendations with the customer.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h2, h11 (type of investigation, investigation findings, medical device ¿ problem code, component codes, investigation conclusions) based on the available information, the reported effects "augmentation malfunction" and "unable to update timing alarm" were confirmed.The augmentation below limit set alarm was observed on pump 1 following a damped arterial waveform and loss of augmentation/support.After the customer exchanged pump 1 for pump 2, the unable to update timing alarm was observed on pump 2.

• 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: 50206138
• Report Number: 2249723-2026-0003792
• Device Sequence Number: 17523169
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: (01)10607567107394
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/24/2026
• 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: Female
• Patient Weight: 114 LB