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

Model Number	0998-UC-3023-53
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
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 preventative maintenance by getinge field service engineer, the cs300 intra-aortic balloon pump (iabp) unit failed battery runtime test.There was no patient involvement.
Additional Manufacturer Narrative
Additional info: contact person(name: (b)(6)) it was reported that during preventive maintenance done by a getinge field service engineer (fse) the cs300 intra-aortic balloon pump (iabp) had failed battery run time test.Fse evaluated the unit and stated that battery runtime of 63 minutes.Minimum runtime spec is 135 minutes.Hense fse resolved the issue by replacing d146-00-0039 battery, sealed lead acid,12v.Fse then performed functional testing and device passed testing.Iabp was then returned to customer for clinical use.The defective components were received for further investigation.The failure analysis and testing dept.Received (2) batteries with a reported unit failure of a failed battery runtime test at 63 minutes.The fat performed a visual inspection and found the part to be in good condition.The fat installed the parts into cs300 test fixture and tested the part to factory specifications and the cs300 service manual.The battery runtime test failed at 54 minutes.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.

• Brand Name: CS300,ENGLISH,NON-UTS,DOM
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 17712751
• Report Number: 2249723-2023-03999
• Device Sequence Number: 6731132
• Product Code: DSP
• UDI-Device Identifier: 10607567108704
• UDI-Public: 10607567108704
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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-UC-3023-53
• Device Catalogue Number: 0998-UC-3023-53
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown