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

Model Number	0998-00-0800-83
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation, below field are added from e1- event site telephone- (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during pm by gentinge fse cardiosave intra aortic balloon pump (iabp) had occurred error code 139.There was no patient involvement.
Additional Manufacturer Narrative
Return to mg.Date missing.Updated fields: b4, d8, d9(device available for eval, return to manufacture date), g3, g6, h2, h3, h6(type of investigation, investigation findings, component codes, investigation conclusions), h11 corrected fields: e1(event site telephone, event site email) a getinge field service engineer (fse) investigated and identified a faulty pim causing a short.The pim (0997-00-1178) was replaced, restoring normal function.No patient was involve the device was tested and left safe for use.The failure analysis and testing dept.Received part pneumatic module assembly with a reported unit failure of error code 139.The failure analysis and testing dept.Performed a visual inspection and observed that the tidal volume disk was missing from the pim (removed).Due to the removal of the tidal volume disk, the fat dept.Cannot investigate this complaint any further.Please note: error code 139 reported by the customer is a communication error between the power management board and the exec processor board.Not caused by the pneumatic module.Please see attachment.Retaining the pneumatic module in the fat per procedure.
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE RESCUE
• 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: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 22975910
• Report Number: 2249723-2025-0003733
• Device Sequence Number: 15840109
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: (01)10607567108407
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/03/2025

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: Other
• Device Model Number: 0998-00-0800-83
• Device Catalogue Number: 0998-00-0800-83
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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