MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE RESCUE, CHINESE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-75
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) machine was turned on, an electrical fault 14 was found during routine inspection.No patients involved, no injuries.
Additional Manufacturer Narrative
Due to character limit in e1 event site telephone number: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
A getinge field service engineer (fse) says hospital did not respond and it is not known whether the repairs will be carried out.If new information and/or device were available, the file would be reopened and updated.
Event or Problem Description
It was reported that during routine inspection when unit was turned on, the cardiosave intra-aortic balloon pump (iabp) had an electrical fault #14.There was no patient involvement.

• Brand Name: CARDIOSAVE RESCUE, CHINESE
• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 20680012
• Report Number: 2249723-2024-0004562
• Device Sequence Number: 7229753
• Product Code: DSP
• UDI-Device Identifier: 10607567112312
• UDI-Public: (01)10607567112312
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: 0998-00-0800-75
• Device Catalogue Number: 0998-00-0800-75
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown