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

Model Number	0998-00-3023-62
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has been presented with the cost estimate to repair the iabp unit.Repairs are pending approval.In the meantime, a loaner unit was sent to the customer.A supplemental report will be submitted if additional information is provided.
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had blurry lines on the display screen.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
Additional Manufacturer Narrative
Updated: b4, b6, b7, d11, e1 (name of initial reporter, email address and telephone #), e2, e3, g4, g7, h2, h10, h11.Corrected: a1, a3, b5, d1, d4 (version or model number, serial number), d10, h3, h6 (type of investigation, component and health effect impact codes).Testing of actual/suspected device (10): a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and was able to observe the reported issue.The fse resolved the issue by replacing the pcb color video receiver and cable dc/ac inverter.The fse performed functional and safety checks to meet 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 a routine check, the cs300 intra-aortic balloon pump (iabp) had blurry lines on the display screen.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Updated fields; b4, g3, g6, g7, h2, h4, h6, h10, h11.Corrected fields: g1.
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 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: 11726737
• Report Number: 2249723-2021-00867
• Device Sequence Number: 4331147
• Product Code: DSP
• UDI-Device Identifier: 10607567108292
• UDI-Public: 10607567108292
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2023

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: Other
• Device Model Number: 0998-00-3023-62
• Device Catalogue Number: 0998-00-3023-62
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 12/17/2021; 01/12/2023
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 01/10/2022; 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2005
• 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: N/A.
• Patient Sex: Prefer Not To Disclose