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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
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 a routine inspection, the cs100 intra-aortic balloon pump (iabp) unit needs a cart wheel replacement.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields: b4, d9, e1 (event site postal code - 1038318), g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h10, h11.Corrected fields: d5, e2, e3, g2.A getinge field service engineer (fse) periodic inspection and part replacement were carried out.The cart wheel was replaced due to damage.Replaced one cart wheel each operating time: 12572 hours bt next replacement date: june 2025 sd next replacement date: june 2025 next replacement time: 13570 hours pm time replacement time: 15000 hours blood sensor power supply check: 3.13v, 1.71v, 2.78v balloon volume: 102mmhg optical sensor: 31, 123, 4.10, 239, 161 dust removal work performed inside the device measuring equipment used: hs-010, hs-023, hs-025 operation confirmed as good.After each work, a regular inspection was performed based on the regular inspection record sheet, and it was confirmed that the equipment is currently in good condition and working.
Additional Manufacturer Narrative
Updated fields: b4, d8, d9 (return to manufacture date), g3, g6, h2, h11 corrected fields: d5, e2, e3 the failure analysis and testing department received part with a reported unit failure of damaged casters.The fat department performed a visual inspection of the parts received and found that all received casters are broken.Due to the broken casters, they cannot be installed and investigated any further.The failure analysis and testing department verified the failure of damaged casters.Retaining the casters in the fat department per procedure 0002-07-d008 rev ar.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.
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, 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 19217296
• Report Number: 2249723-2024-01795
• Device Sequence Number: 12810538
• Product Code: DSP
• UDI-Device Identifier: 10607567108674
• UDI-Public: (01)10607567108674(21)SA05094-B6
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/04/2025

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: Health Professional
• Device Model Number: 0998-UC-3013-65
• Device Catalogue Number: 0998-UC-3013-65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 07/01/2024; 12/20/2024; 02/04/2025
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/15/2024; 01/08/2025; 02/04/2025
• 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