MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-61
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1 telephone number : (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that while moving the cs300 intra-aortic balloon pump (iabp) device from cardiology storage unit to the operating room, the holding arm broke off and needs to be replaced.There was no patient involvement.
Additional Manufacturer Narrative
Due to character restrictions in block telephone number : (b)(6).
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and was able to confirm the reported issue and the retaining arm needs to be replaced.The part was not replaced because the device has been ¿end of service¿ in dach for years or only maintenance work is being carried out on the devices.The eos letter was sent to the customer.Repairs can no longer be carried out on the device or will no longer be carried out.
Additional Manufacturer Narrative
Udi related data quality updates only: providing updated device identification information in alignment with gudid.
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 220V
• 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: 18730630
• Report Number: 2249723-2024-00713
• Device Sequence Number: 20902080
• Product Code: DSP
• UDI-Device Identifier: 10607567108278
• UDI-Public: (01)10607567108278
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063525
• 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,Followup,Followup
• Report Date (Section B): 10/17/2024

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: 0998-00-3023-61
• Device Catalogue Number: 0998-00-3023-61
• 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: 02/05/2024
• Supplement Date Received by Manufacturer: 02/21/2024; 02/28/2024; 10/17/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 02/22/2024; 02/28/2024; 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2008
• 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