MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE BATTERY CHARGING STATION; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0802
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during installation the cardiosave intra-aortic balloon pump (iabp) left side battery charger is not charging the batteries.No patient involvement.No harm was reported.The fse reported that there are no servicable parts for charger.Could not complete repair on this device as no service parts are available for this device.The charging station still charges batteries in right bay.The fse reported that repair/replacement of the charging station is not going to take place.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Additional Manufacturer Narrative
Corrected fields: d1, d4, h4.Updated fields: b5, h11.Following a re-evaluation, it was determined that the previously reported device, cardiosave rescue (model 0998-00-0800-83, serial number (b)(6)), should not have been included in this report.The complaint pertains to an accessory, specifically an external battery charging station, which is a separate device and does not represent an allegation of malfunction involving the compatible cardiosave pump.Furthermore, a malfunction of the external battery charging station would not impact the functionality of the cardiosave pump, as the charger is an external accessory and is not a component required for pump operation during therapy.Based on the available information, this complaint was determined to be non-reportable.

• Brand Name: CARDIOSAVE BATTERY CHARGING STATION
• 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: 50445646
• Report Number: 2249723-2026-0003986
• Device Sequence Number: 9762701
• Product Code: DSP
• UDI-Device Identifier: 10607567111964
• UDI-Public: (01)10607567111964
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: 0998-00-0802
• Device Catalogue Number: 0998-00-0802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown