MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 UTS INTRA-AORTIC BALLOON PUMP SPANISH 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-87
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge field service engineer (fse) inspected the unit with new ecg input cable.The fse was unable to reproduce the reported issue.No fault observed with ecg amplitude.The fse tested unit with trainer and balloon, and with the same ecg input trigger.The unit was released to the customer in good condition and cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that before use the external ecg input on the cs100 intra-aortic balloon pump (iabp) was detecting low amplitude.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, e1(site country), g3, g6, h2, h4, h6(type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected filed: d5, e1(event site telephone: (b)(6).Additional information: e1(event site state: (b)(6)).
Event or Problem Description
N/a.

• Brand Name: CS100 UTS INTRA-AORTIC BALLOON PUMP SPANISH 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: 13862974
• Report Number: 2249723-2022-00616
• Device Sequence Number: 5264454
• Product Code: DSP
• UDI-Device Identifier: 10607567108100
• UDI-Public: 10607567108100
• 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
• Report Date (Section B): 03/05/2024

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: 0998-00-3013-87
• Device Catalogue Number: 0998-00-3013-87
• Device Lot Number: N/A
• 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: 02/26/2022
• Supplement Date Received by Manufacturer: 02/24/2024
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown