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

Model Number	0998-00-0800-53
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) gave a gas loss alarm.The unit was swapped out with another to continue therapy.No patient harm, serious injury or adverse event was reported.
Additional Manufacturer Narrative
Testing of actual/suspected device (10/213): a getinge field service engineer (fse) was dispatched to evaluate the iabp.To fix the issue, the fse started unit and ran on a test balloon no indication of helium leaking.The unit went through the helium leak tests as per the service manual, all passed and within factory specs.The fse reassembled the unit and it ran on the test balloon with no issues and a complete calibration and electrical safety test.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) gave a gas loss alarm.The unit was swapped out with another to continue therapy.No patient harm, serious injury or adverse event was reported.
Event or Problem Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) gave a gas loss alarm.The unit was swapped out with another to continue therapy.No patient harm, serious injury or adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID, TYPE B 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: 12846823
• Report Number: 2249723-2021-02662
• Device Sequence Number: 17194880
• Product Code: DSP
• UDI-Device Identifier: 10607567108094
• UDI-Public: 10607567108094
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2023

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 10/29/2021; 10/06/2023
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 02/24/2022; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown