MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-61
Medical Device Problem Codes	Device Alarm System (1012); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during routine check, the cs300 intra-aortic balloon pump (iabp) alarm went off.There was no patient involvement.
Additional Manufacturer Narrative
It was reported that during routine check the cs300 intra-aortic balloon pump (iabp) had a issue of alarm - unknown / unspecified.There was no patient involvement.A getinge field service engineer (fse) stated no parts broken, the problem is that this equipment isn't under getinge agreement and they didn´t do any action or preventive since 2019.Fse informed the customer that the equipment can't be used in this conditions.Fse did a preventive maintenance and says once the customer signed the report he will upload it.This report is only to diagnostic, a preventive maintenance needed and he inform the customer.In this report ins't the preventive maintenance, there is another (b)(4) to the preventive maintenance.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.
Additional Manufacturer Narrative
It was reported that during routine check the cs300 intra-aortic balloon pump (iabp) had a issue of alarm - unknown / unspecified.A getinge field service engineer (fse) evaluated the unit the ballom pump haven't the preventive maintenance since 2019, it was fully of dust, the safety disk was expired and with over hours, the membranes of compressor need to be changed.So many problems generated because the preventive maintenance was not done.Fse informed the customer sometimes that they need to do the preventive maintenance last years.The alarm in the cs300 was blood detected but not blood in the equipment after start up, to much dust generate the alarm.The preventive maintenance was done and the cs300 is working perfect now.The service order only inform the customer that the cs300 need the preventive maintenance, no fault with the cs300 because something was broken, only needed preventive maintenance.
Additional Manufacturer Narrative
Providing updated device identification information in alignment with gudid.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 220V
• 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: 19216431
• Report Number: 2249723-2024-01773
• Device Sequence Number: 6903911
• Product Code: DSP
• UDI-Device Identifier: 10607567108278
• UDI-Public: (01)10607567108278(21)SI100413H7
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/31/2025

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: 0998-00-3023-61
• Device Catalogue Number: 0998-00-3023-61
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 07/23/2024; 08/29/2024; 01/31/2025
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/23/2024; 08/29/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown