MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3013-65
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during transportation, the cs100 intra-aortic balloon pump (iabp) battery stopped working after about 5 minutes.It was used in conjunction with ecmo and currently in continuous use with ac drive.There was no patient harm reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that the unit became unusable when used in conjunction with ecmo therapy after 5 minutes.The customer chose not to repair the unit.
Additional Manufacturer Narrative
Udi related data quality updates only.Providing updated device identification information in alignment with gudid.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM
• 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: 17951517
• Report Number: 2249723-2023-04479
• Device Sequence Number: 20512021
• Product Code: DSP
• UDI-Device Identifier: 10607567108674
• UDI-Public: (01)10607567108674(21)SA06340-L6
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2024

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-UC-3013-65
• Device Catalogue Number: 0998-UC-3013-65
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 03/14/2024; 09/20/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 03/15/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown