MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-45
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not accessible for testing: device is not accessible for testing due to the customer not requesting repair service.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.The full name of the event site is (b)(6) hospital.
Event or Problem Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) display appeared black during transport.No patient harm, serious injury or adverse event was reported.
Additional Manufacturer Narrative
Testing of actual/suspected device (10): a getinge service representative reported that the engineer replaced the motor control board and the purge valve assembly to fix the reported issue.All functional and safety checks to meet factory specifications were performed.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A getinge authorized dealer's filed service engineer was the one who performed the repair that was mentioned in mfg follow-up #1.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields; b4, g3, g6, g7, h2, h4, h6, h10, h11.Corrected fields: d1, d4, d9, g1.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V
• 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: 12300257
• Report Number: 2249723-2021-01752
• Device Sequence Number: 17047145
• Product Code: DSP
• UDI-Device Identifier: 10607567111957
• UDI-Public: 10607567111957
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031636
• 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): 01/06/2023

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: 0998-00-3013-45
• Device Catalogue Number: 0998-00-3013-45
• 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: 07/16/2021
• Supplement Date Received by Manufacturer: 12/01/2021; 12/16/2021; 01/06/2023
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 12/16/2021; 01/07/2022; 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2008
• 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.; UNKNOWN.
• Patient Age: 74 YR
• Patient Sex: Female