MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE J PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-32
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1: event site address: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during unrelated servicing by the getinge field service engineer (gfse), when initializing the cardiosave intra-aortic balloon pump (iabp) it showed a start-up test failure with code 05.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h4, h6 ( type of investigation, investigation findings, investigation conclusion), h10 a getinge field service engineer (fse) checked and found that the shuttle value (x1) was completely out of atmospheric.A calibration attempt had been unsuccessful, therefore, it will be necessary to replace the pneumatic interface module (pim) and make a new calibration at the act of installation.Fse stated that the customer did not give any response regarding the budget sent so the device is not repaired.As of now the investigation is closed, if any new information received in future related to part replacement will reopen the complaint and update it.
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE J PLUG
• 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: 17844529
• Report Number: 2249723-2023-04278
• Device Sequence Number: 4312593
• Product Code: DSP
• UDI-Device Identifier: 10607567111117
• UDI-Public: 10607567111117
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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: 0998-00-0800-32
• Device Catalogue Number: 0998-00-0800-32
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown