MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 8FR. 50CC IAB (WITH STATLOCK); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0296-01
Medical Device Problem Codes	Leak/Splash (1354); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2025
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 by nurse (b)(6) that a gas loss alarm on an iabp pump that had been in standby for about 10 minutes.After initial troubleshooting steps, the pump resumed normal function, but during the discussion, it alarmed for gas gain and later gas loss again.(b)(6) verified helium tubing integrity, checked all connections, and decreased the augmentation level by 2, which resolved the issue temporarily.I advised that if gas loss or gas gain alarms recur, the pump should be exchanged.There was no harm reported.
Event or Problem Description
It was reported by the customer to the emergency support program.Nurse called to request assistance with a gas loss alarm.Nurse stated the pump had been in standby for 10 minutes.(b)(6) performed proper troubleshooting: verify the helium tubing had no blood or discoloration.Press the iab fill key for 2-3 seconds, press start, and check the helium tubing again.The pump resumed without issue.Reviewed the nature of this alarm and different clinical possibilities.The patient was ventilated with a peep of 5.During our discussion, the pump alarmed gas gain.(b)(6) had performed proper troubleshooting again.(b)(6) also encouraged her to check all the connections on the helium tubing to ensure they were connected.The pump alarmed gas loss again, and she resolved the issue.(b)(6) had her decrease the augmentation level by 2.(b)(6) explained if the pump alarmed gas loss or gas gain again, then she would need to exchange the pump.(b)(6) encouraged her to call me directly should it occur.(b)(6) collected product surveillance information.(b)(6) did not receive another call back from (b)(6) on my shift.
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2, h3, h11 corrected fields: b5, d1, d4 version/model number, catalog number, udi number, expiry date it was reported by the customer to the emergency support program.Nurse called to request assistance with a gas loss alarm.Nurse stated the pump had been in standby for 10 minutes.(b)(6) performed proper troubleshooting: verify the helium tubing had no blood or discoloration.Press the iab fill key for 2-3 seconds, press start, and check the helium tubing again.The pump resumed without issue.Reviewed the nature of this alarm and different clinical possibilities.The patient was ventilated with a peep of 5.During our discussion, the pump alarmed gas gain.(b)(6) had performed proper troubleshooting again.(b)(6) also encouraged her to check all the connections on the helium tubing to ensure they were connected.The pump alarmed gas loss again, and she resolved the issue.(b)(6) had her decrease the augmentation level by 2.(b)(6) explained if the pump alarmed gas loss or gas gain again, then she would need to exchange the pump.(b)(6) encouraged her to call me directly should it occur.(b)(6) collected product surveillance information.(b)(6) did not receive another call back from (b)(6) on my shift.

• Brand Name: MEGA 8FR. 50CC IAB (WITH STATLOCK)
• 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: 23566972
• Report Number: 2248146-2025-0000737
• Device Sequence Number: 13292060
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: (01)10607567108001(10)3000452583(17)280210(11)250210
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: 0684-00-0296-01
• Device Catalogue Number: 0684-00-0296-01
• Device Lot Number: 3000452583
• 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: 10/26/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2025
• 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: CARDIOSAVE PUMP.
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 94 KG