MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID, TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-45
Medical Device Problem Codes	Failure to Power Up (1476); Charging Problem (2892); Power Problem (3010); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2024
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, when the cardiosave intra-aortic balloon pump (iabp) is turned on, the ac power indicator light is normal, but the battery can not be charged and the host has no power supply function, resulting in the machine being unable to turn on.There was no patient involvement.
Additional Manufacturer Narrative
Corrected data: d4 (serial#) updated data: b4, g3, g6, h2, h10, h11.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Udi related data quality updates only.Providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).
Additional Manufacturer Narrative
A getinge field service engineer (fse) confirmed the aortic balloon pump could not be turned on.After maintenance, it was determined that the power management board was broken.The power management board (d670-00-1162) was replaced and the device was turned on for testing.The device passed the pre-use inspection.The device passed all factory-specified performance and safety index tests.The device has been delivered to the customer and can be used clinically.There was no patient involvement.The defective components were not further investigated due to being lost in transit.
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE HYBRID, TYPE I PLUG
• 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: 19282209
• Report Number: 2249723-2024-01927
• Device Sequence Number: 18040316
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: (01)10607567108421(21)CH385015A4
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/26/2026

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: 0998-00-0800-45
• Device Catalogue Number: 0998-00-0800-45
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 05/10/2024; 02/11/2025; 02/25/2026
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/14/2024; 02/11/2025; 02/26/2026
• 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: N/A.
• Patient Sex: Unknown