MAUDE Adverse Event Report: DATASCOPE CORP. SYSTEM 98XT; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0446-64
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
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, the cs300 intra-aortic balloon pump (iabp) unit's blood cell was defective and required replacement.
Additional Manufacturer Narrative
Corrected data: b5, b6, b7, d5, d10, e1 (initial reporter and email), e2, e3, e4, h6 (clinical and impact code).Updated data: b4, g3, g6, h2, h10, h11.
Event or Problem Description
It was reported that during preventative maintenance by getinge field service engineer, the cs300 intra-aortic balloon pump (iabp) unit's blood detection cell was defective and required replacement.There was no patient involved.
Additional Manufacturer Narrative
In order to fix the issue, the getinge field service engineer (fse) replaced the part.The fse then stated that all functional control was ok, electrical safety test was ok, cell voltage control ok, and functional equipment according to the manufacturer's protocol.
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).Suspect device originally distributed as a sys98xt, upgraded to cs300 using conversion kit.No udi is provided as product was discontinued prior to gudid implementation timeline.

• Brand Name: SYSTEM 98XT
• 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: 18384556
• Report Number: 2249723-2023-05480
• Device Sequence Number: 11437815
• Product Code: DSP
• UDI-Device Identifier: 10607567107509
• UDI-Public: 10607567107509
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K961509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/29/2024

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: 0998-00-0446-64
• Device Catalogue Number: 0998-00-0446-64
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/05/2024; 01/30/2024; 09/29/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/11/2024; 02/01/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/1999
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown