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

Model Number	0998-00-0800-32
Medical Device Problem Codes	Battery Problem (2885); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the during the technical visit cardiosave intra-aortic balloon pump (iabp) did not pass battery test and the safety disc was expired.There was no patient involvement reported.
Additional Manufacturer Narrative
Due to character limitation in e1 for event site name, the full event site name is (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
The complaint record is cancelled as the new information provided does not meet the criteria of a complaint per the complaint handling procedure.In the event, additional reportable information is received, the complaint will be reopened and new information will be submitted.
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE J 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21025883
• Report Number: 2249723-2024-0005302
• Device Sequence Number: 8367602
• Product Code: DSP
• UDI-Device Identifier: 10607567111117
• UDI-Public: (01)10607567111117
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: 0998-00-0800-32
• Device Catalogue Number: 0998-00-0800-32
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 04/24/2025
• Date Device Manufactured: 07/16/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown