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

Model Number 0998-00-3023-55

Device Problems Electrical /Electronic Property Problem (1198); Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

It was reported that the customer has decided to purchase a new iabp as opposed to repairing the cs300 intra-aortic balloon pump.It is unknown what required repair or what the malfunction was.It is also unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Manufacturer Narrative

Type of investigation not yet determined: (4118/3233): a supplemental report will be submitted upon receipt of additional information.

Manufacturer Narrative

Device not accessible for testing (4117): a getinge field service engineer (fse) spoke to the customer who indicated that a new iabp will be purchased.The cs300 reported will not be repaired.A supplemental report will be submitted upon completion of our evaluation.H3 other text : not returned to manufacturer.

Event Description

It was reported that the transducer calibration on the cs300 intra-aortic balloon pump (iabp) failed.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Event site postal code: (b)(6).A getinge field service engineer (fse) confirmed and stated to resolve the issue by replacing parts d670-00-0668 pcb,front end module, d670-00-0788 pcb,iabp main board, d670-00-0639e exch pcb, solenoid driver and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released and cleared for clinical service.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 14 philips parkway; montvale NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13638864
• MDR Text Key: 290000790
• Report Number: 2249723-2022-00417
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• UDI-Public: 10607567112541
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024

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
• Device Operator: Other
• Device Model Number: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 03/02/2022; 03/02/2024
• Supplement Dates FDA Received: 03/30/2022; 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2009
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.