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 Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.After further review, an initial emdr for this complaint was incorrectly submitted.This is a non-reportable event, making it non-reportable to the fda.As a result, no follow up emdr is necessary.Please cancel this report 2248146-2026-0000853 in your database.
Event or Problem Description
N/a.
Event or Problem Description
Tatum, a perfusionist in the or, called for no numbers on the pump after placing the iabp in the or.She stated that the pump displayed an ¿unable to calibrate¿ alarm with no numerical values following insertion, although pumping was confirmed by the balloon waveform.The issue occurred while the patient was coming off bypass and resolved after approximately 30 minutes as the patient¿s hemodynamics improved, with numerical values returning.Based on the clinical conditions, the issue was most likely related to low pulse pressure rather than a device malfunction; no other issues were reported.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Other contact phone number: (b)(6).Tatum, a perfusionist in the or, called for no numbers on the pump after placing the iabp in the or.She stated that the pump displayed an ¿unable to calibrate¿ alarm with no numerical values following insertion, although pumping was confirmed by the balloon waveform.The issue occurred while the patient was coming off bypass and resolved after approximately 30 minutes as the patient¿s hemodynamics improved, with numerical values returning.Based on the clinical conditions, the issue was most likely related to low pulse pressure rather than a device malfunction; no other issues were reported.No harm or injury to the patient was reported.

• 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: 24788631
• Report Number: 2248146-2026-0000853
• Device Sequence Number: 15654846
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: (01)10607567108605(10)3000495519(17)280821(11)250821
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/10/2026

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: 3000495519
• 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: 03/15/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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: UNKNOWN.
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 93 KG