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	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a routine inspection, the cs100 intra-aortic balloon pump (iabp) unit has caster damage.There was no patient involvement.
Additional Manufacturer Narrative
Due to character restrictions in block e1 event site name : (b)(6) office.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - (event site postal code - (b)(6).A getinge fse was dispatched to evaluate the unit.Two on the front side (recorder side) and one on the back side (power cord side) were damaged and replaced.The failure analysis and testing dept.Received part with a reported unit failure of caster damage.The fat performed a visual inspection and found the parts to have damage to the wheels.Fat was able to verify the reported issue.Retaining the part in the failure analysis and testing department per procedure number 0002-07-d008 rev.Ap.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.
Event or Problem Description
N/a.
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, 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 18007625
• Report Number: 2249723-2023-04608
• Device Sequence Number: 15354456
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: (01)10607567107684(21)SA05677-F6
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/25/2024

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: Other
• Device Model Number: 0998-00-3013-65
• Device Catalogue Number: 0998-00-3013-65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 04/25/2024; 05/17/2024; 09/25/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 05/16/2024; 05/17/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose