MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-65
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block (b)(6) a supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during regular inspection, the wheels of the cart of the cs100 intra-aortic balloon pump (iabp) unit are broken.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11 corrected field: d4 udi number a getinge field service engineer (fse) evaluated the unit and carts wheel.One of the cart was replaced.After each operation, the operation was confirmed based on the inspection record sheet and it was confirmed that it is currently in good condition and working.These parts were received with a reported unit failure message of casters broken.Performed visual inspection of these parts received and found both casters were broken.Please see attached picture.The fat dept.Verify the failure message of casters broken.Retaining both parts in the fat dept.Per procedure 0002-07-d008 rev ar.The most probable root cause for the reported is normal wear and tear.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V
• 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: 19536214
• Report Number: 2249723-2024-02534
• Device Sequence Number: 12824952
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: (01)10607567107684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031636
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 0998-00-3013-65
• Device Catalogue Number: 0998-00-3013-65
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 12/05/2024; 02/13/2025
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 12/24/2024; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown