MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-65
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1event site name: federation of national public service personnel mutual aid associations meijo hospital 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) if units negative pressure of the compressor is insufficient alarm occurs multiple times.There was no health damage reported.
Additional Manufacturer Narrative
Updated fields: b4,d9,e1(site country),g3,g6,h2,h3,h4,h6(type of investigation, investigation findings, component codes,investigation conclusions), h10 additional fields:e1(event site address: (b)(6), event site telephone: (b)(6).It was reported that the device the cs300 intra-aortic balloon pump (iabp) will be used from (b)(6) 2023.If the compressor's negative pressure is insufficient alarm occurs multiple times during use, the will contact you by phone to inquire about the cause of the alarm and what to do about it.When they informed them of the cause of the negative pressure shortage alarm and told them that they would consider replacing it with another iabp device, they said that they would continue using it as they were scheduled to leave the iabp tomorrow.Regarding the frequency of alarm occurrences, there were times when the alarm occurred up to three times an hour, and times when there were no alarms.Getinge field service engineer (fse) manifold driver replacement was carried out, and at the same time regular inspections were carried out.We determined that there was no problem with the post-repair inspection, and delivered the cs300 to the hospital.There was patient involvement but no patient harm.The defective components were received for further investigation.The failure analysis and testing dept.Received part number (b)(4) manifold drive, serial number (b)(6) with a reported unit failure of if the negative pressure of the compressor is insufficient, alarms occur multiple times.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.The failure analysis and testing dept.Installed part number (b)(4) manifold drive, serial number (b)(6) into the cs300 test fixture serial number (b)(6) , and tested the drive manifold to factory specifications per the cs300 service manual part number (b)(4) revision w.The fat performed a k6,k6a, k7, k8 leak test.The test passed.The fat could not replicate the failure the customer experienced of the unit going to a negative pressure and alarming.The drive manifold passed testing.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V
• 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: 16456138
• Report Number: 2249723-2023-01319
• Device Sequence Number: 6239880
• Product Code: DSP
• UDI-Device Identifier: 10607567108803
• UDI-Public: 10607567108803
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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: 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2023
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Unknown