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

Model Number	0998-00-3013-87
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse confirmed the issue.The main board and both datasettes were replaced.The iabp functions correctly now.
Event or Problem Description
It was reported that during a routine check by the customer, the cs100 intra-aortic balloon pump (iabp) alarm was not functioning.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Trend analysis: (4110/102) the overall 24 month product complaint trend data for the period may 2019 through apr 2021 was reviewed.There were no triggers identified for the review period.Iabp has been returned to the customer and cleared for clinical use.

• Brand Name: CS100 UTS INTRA-AORTIC BALLOON PUMP 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11770063
• Report Number: 2249723-2021-00935
• Device Sequence Number: 3192173
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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
• 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: 04/16/2021
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown