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

Model Number	0998-00-3023-57
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during patient use, the cs300 intra-aortic balloon pump (iabp) displayed "check iab catheter" alarm and would not pump, after the patient was switched to this replacement iabp unit involved from another cs300 iabp unit, whereby an unrelated issue of an "optical sensor failure" message displayed, the pump stopped at times on it's own and needed to be started again.The initial reporter also reported that the patient was then placed back on the original cs300 iabp unit, at which time, the unit was pumping despite the message "optical sensor failure" that was still displayed.The initial reporter reached out to a third-party technician for help.Moreover, the initial reporter reported that troubleshooting was not attempted as the end users had no training on the iabp units.Furthermore, the initial reporter stated that an english speaking person will not be available to communicate with the getinge representative.The getinge representative informed the initial reporter that a getinge service tech will attempt to speak to the initial reporter, if available.Although it was reported that patient therapy was delayed, there was no harm or injury to the patient and no adverse event was reported.This report is for the second iabp used.The first and final iabp is being reported separately.
Additional Manufacturer Narrative
At this time, the customer has not requested getinge to evaluate the iabp.Attempts are being made to obtain additional information with regard to the repair and status of the iabp unit.A supplemental report will be submitted when this information is provided to us.The full address of the event site was shortened due to field character limit; the full address is (b)(6).Patient height 180cm.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
At this time, the customer has not requested getinge to evaluate the iabp.Reached out to customer via email who informed us unit is still awaiting repair as their service provider is still waiting for parts.Customer reached out to 3rd party vendor, vital life, for service.The vital life tech assured customer that pump is okay to use.If information is received, we will reopen and update the complaint.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 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: 12721685
• Report Number: 2249723-2021-02504
• Device Sequence Number: 4028215
• Product Code: DSP
• UDI-Device Identifier: 10607567108254
• UDI-Public: 10607567108254
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: K063525
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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: 0998-00-3023-57
• Device Catalogue Number: 0998-00-3023-57
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2014
• 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 Age: 62 YR
• Patient Sex: Male