MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-65
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1 event site name : (b)(6) medical.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use, the cs300 intra-aortic balloon pump (iabp) unit has poor screen display.There was no harm reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid.
Additional Manufacturer Narrative
Updated field: b4, d8, d9, g1(contact office, contact person ¿ mfg site), g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.A getinge field service engineer (fse) observed video receiver board and display cable were damaged.Fse replaced video receiver board and display to video receiver cable.Display is good, drive test, good results.Unit returned for clinical use is unknown.There was patient involved, no harm reported.The failure analysis and testing dept.Received the following parts associated with this complaint:pcb, color video receiver cable, display to video receiver these parts were received with a reported unit failure of screen display failure and damaged parts.The failure analysis and testing dept.Performed a visual inspection and found part pcb, color video receiver serial number (b)(6) had a scrape across the land and part cable, display to video receiver serial number (b)(6) had a slight crease on the cable.The fat dept.Tested the parts because the damage to these parts was minimal.The failure analysis and testing dept.Installed part pcb, color video receiver serial number (b)(6) and part cable, display to video receiver serial number (b)(6) into the cs300 test fixture serial number (b)(6) and tested the parts to factory specifications per the cs300 service manual part number 0070-00-0689 rev.W.After 1.5 hours of run time, the fat dept.Could not replicate the complaint of screen display failure.The damage the customer stated in the complaint did not contribute to the screen display failure.The parts passed testing.Root cause grid will be not confirmed for the screen display failure.For the damage, operational context.Retaining the parts in the fat dept.Per procedure number 0002-07-d008 rev.As.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.

• Brand Name: CS300 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: 18401421
• Report Number: 2249723-2023-05502
• Device Sequence Number: 3968063
• Product Code: DSP
• UDI-Device Identifier: 10607567108803
• UDI-Public: (01)10607567108803(21)SI01160-A7
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063525
• 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): 02/27/2025

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-3023-65
• Device Catalogue Number: 0998-UC-3023-65
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 09/30/2024; 02/10/2025
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 10/02/2024; 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown