MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID, TYPE B PLUG; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-53
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use the cardiosave intra aortic balloon pump (iabp) batteries stopped charging.After this event occurred, this iabp unit was continued to be used throughout iabp therapy for this patient.As this iabp unit was connected to ac power source, this event did not affect continuing iabp therapy.There was no patient harm.A getinge field service engineer (fse) evaluated the unit and found that the power management board, which controls power and charging, was faulty.Therefore, the power management board was replaced.After the replacement, multiple discharge/charge cycles were repeated, and charging was confirmed to be normal.After the work was completed, an inspection was conducted based on the service manual, with good results.
Additional Manufacturer Narrative
Due to characterization limit e1: initial reporter name: (b)(6).A getinge field service engineer (fse) evaluated the unit and found that the power management board, which controls power and charging, was faulty.Therefore, the power management board was replaced.After the replacement, multiple discharge/charge cycles were repeated, and charging was confirmed to be normal.After the work was completed, an inspection was conducted based on the service manual, with good results.The failure analysis and testing dept.Received part with a reported unit failure of the batteries stopped charging.The fat performed a visual inspection and found the part to have a blown q27 component.See attachment.This is a known failure and is due to a design issue.Retaining the part in the failure analysis and testing department per procedure.Rc1 ¿ there is no surge protection in the interface between the charging circuitry and the batteries installed in the power slots of the unit.Rc2 ¿ the tantalum capacitors used on the following two (2) pcbas are not within the capacitor manufacturer¿s (vishay) de-rating guidelines which may result in capacitor failure causing an overcurrent condition on the vbulk power supply which damages the power management board.

• Brand Name: CARDIOSAVE HYBRID, TYPE B 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: 50929828
• Report Number: 2249723-2026-0004475
• Device Sequence Number: 16136162
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Unknown.
• Patient Sex: Unknown