MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0576-01
Medical Device Problem Codes	Pacing Problem (1439); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) an icu rn called into the emergency support program line on behalf of (b)(6) fellow requesting assistance for a dampened arterial waveform.She reported that the pump was using the transducer as the ap source due to a fo sensor failure.A screenshot of the iabp monitor revealed the pump was in semiauto mode using pressure trigger an ecg waveform with significant artifact and an arterial waveform with significant artifact.(b)(6) stated she had troubleshot the arterial waveform by flushing every four hours and had successfully aspirated and replaced the entire transducer setup without improvement.Esp personnel recommended obtaining a chest x ray to ensure the distal marker was positioned between the second and third intercostal space.For the ecg waveform esp personnel recommended replacing the ecg electrodes applying doppler gel to the back of each electrode optimizing electrode placement to improve conduction and considering a switch back to automode.(b)(6) the dayshift charge rn later sent a screenshot of the most recent chest x ray which showed the distal marker in the fourth intercostal space.Esp personnel explained getinge recommended positioning of the radiopaque marker between the second and third intercostal space.Melissa stated this differed from prior teaching and that she would consult the physician.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id (b)(4).

• Brand Name: SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 24856460
• Report Number: 2248146-2026-0000887
• Device Sequence Number: 9009030
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: (01)10607567108605(10)3000509516(17)281028(11)251028
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0576-01
• Device Lot Number: 3000509516
• 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: 03/22/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IABP
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 93 KG