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

Model Number	0998-00-3013-68
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 during preventive maintenance (pm) performed by a getinge service territory manager (stm) , it was necessary to replace two cs100 intra-aortic balloon pump (iabp) casters as they had damaged rubber.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: (b)(6).It was reported that cs100 intra aortic balloon pump (iabp) had defective casters.There was no patient involvement and no harm reported.A getinge field service engineer (fse) evaluated and says it is necessary to replace 2 balloon casters as they have damaged rubber and fse replaced the casters.Also, according to the conversation with the customer it was decided that 2 lead batteries will be ordered as the customer replaces it every 2 years to avoid any problem with the battery charges and the 2 year period comes in (b)(6) 2024, so it will be replaced when they have the next preventive maintenance in 6 months.Safety disk expires in october 2024 and will be ordered in this service network to allow time for delivery and have all parts in precaution of october/2024.5000 hours kit was replaced in (b)(6) 2022 and does not require replacement at the moment.Safety disk number: (b)(4)., next replacement with 7810.2 hours or in (b)(6) 2024 whichever comes first, equipment currently has 7046.4 hours of use, therefore it has been used 1236 hours since 10/2022.Hour meter with 7046.4 hours of total equipment use.Functional tests have been carried out and the equipment is released for use.
Event or Problem Description
N/a.
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, PORTUGUESE, 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: 19271021
• Report Number: 2249723-2024-01905
• Device Sequence Number: 20578292
• Product Code: DSP
• UDI-Device Identifier: 10607567107691
• UDI-Public: (01)10607567107691(21)SA03593-C5
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2025

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: Other
• Device Model Number: 0998-00-3013-68
• Device Catalogue Number: 0998-00-3013-68
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/28/2024; 02/05/2025
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 07/09/2024; 02/05/2025
• 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