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

Model Number	0998-00-3013-68
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the cs100 intra-aortic balloon pump (iabp) informed failure (does not cycle) was provided by the hospital's clinical engineering, which did not have knowledge about the equipment.The equipment will still be evaluated correctly, using the trainer and an original catheter.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h2, h10, h11.Corrected data: b5, b6, b7, d10, h6 (clinical & impact).
Event or Problem Description
It was reported that during inspection, the cs100 intra-aortic balloon pump (iabp) informed failure (does not cycle) was provided by the hospital's clinical engineering, which did not have knowledge about the equipment.The equipment will still be evaluated correctly, using the trainer and an original catheter.There was no patient involvement.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: (site country, state, site city, address), ( type of investigation, investigation findings, investigation conclusion).Additional information: event site city: (b)(6).The getinge field service technician (fst) has not received customer po approval to proceed with the identified repairs.If any pertinent information is received in the future, a supplemental report will be submitted.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 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: 16530661
• Report Number: 2249723-2023-01467
• Device Sequence Number: 14179322
• Product Code: DSP
• UDI-Device Identifier: 10607567107691
• UDI-Public: 10607567107691
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K031636
• 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): 04/19/2024

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: Other
• Device Model Number: 0998-00-3013-68
• Device Catalogue Number: 0998-00-3013-68
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 03/17/2023; Not provided
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 03/28/2023; 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2018
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; UNKNOWN.
• Patient Sex: Unknown