MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS 100 IABP PROCESS FMEA AND REPORT; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0060-00-1971
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2022
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 cs100 intra-aortic balloon pump (iabp) unit had a low battery backup error.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields: b4,g3,g6,h2,h4,h6(health effect-clinical code),h10.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4,d9,g3,g6,h2,h3,h6(type of investigation, investigation findings, investigation conclusions), h10,h11.Corrected fields: d1,d4(catalog#,version#) additional fields: e1(event site state: (b)(6).It was reported that the cs100 intra-aortic balloon pump (iabp) had a low battery alarm.There is no patient involvement.A getinge field service engineer checked machine and found that the battery status indicator on screen was showing empty and showing low battery backup.Charging volt is proper and tested machine on battery on system trainer and machine working more than 45 min.Suspected the power supply is defective.No parts replaced as the customer did not approve po for power supply.As per the discussion had with customer they have resolved the problem by themselves.Also in last pm this problem was not observed and unit is in clinical use.
Event or Problem Description
N/a.

• Brand Name: CS 100 IABP PROCESS FMEA AND REPORT
• 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: 17324571
• Report Number: 2249723-2023-03171
• Device Sequence Number: 20214629
• Product Code: DSP
• UDI-Device Identifier: 10607567107745
• UDI-Public: 10607567107745
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 04/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: 0060-00-1971
• Device Catalogue Number: 0060-00-1971
• 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: 03/06/2022
• Supplement Date Received by Manufacturer: 02/25/2024; 04/08/2024
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 03/20/2024; 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2016
• 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