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

Model Number	0998-00-0800-83
Medical Device Problem Code	Failure to Zero (1683)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation in e1: full initial reporter name: (b)(6).A getinge field service engineer (fse) was dispatched to evaluate the unit.Inspected unit bp connection on front end board for signs of damage, none noted.Connected trainer and noted normal bp readings on unit, indicating console side working normally.Inspected bp adapter cable and bp cables provided by customer, noted bp adapter cable connector spinning when being tightened down.Internal wiring in bp adapter cable damaged, replaced 8 cable assembly, blood pressure with customer provided replacement.Connected bp transducer and obtained zero reading indicating new adapter cable working properly performed functional testing and safety checks.Unit passed all functional and safety tests per factory specifications, returned unit to customer.
Event or Problem Description
It was reported by the customer that the cardiosave intra-aortic balloon pump (iabp) was unable to zero pressure line while on patient.Patient was transported without issue and unit set aside once patient was off iabp.No patient harm reported.

• 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21966648
• Report Number: 2249723-2025-0002097
• Device Sequence Number: 8177525
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: (01)10607567108407
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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: Health Professional
• Device Model Number: 0998-00-0800-83
• Device Catalogue Number: 0998-00-0800-83
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 05/06/2025
• 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: UNKNOWN.
• Patient Sex: Unknown