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

Model Number	0998-UC-3013-58
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit and noted that the sensor was a bit out of adjustment.The fse adjusted the potentiometer of the barometric pressure sensor and the issue was fixed.The fse then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had an error1-stop.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, d4 (model#), g4, g7, h2, h6 (type of investigation, component codes, health effect - impact codes), h10, h11 corrected fields: d4 (catalog#, unique identifier (udi)#), h4, h6 (health effect - clinical code).Historical data analysis: (4109/114) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110/114) the overall 12 month product complaint trend data for the period (enter timeframe) was reviewed.There were no triggers identified for the review period.Analysis of production: (3331/114) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.
Event or Problem Description
N/a.

• Brand Name: CS100
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11287116
• Report Number: 2249723-2021-00215
• Device Sequence Number: 17030114
• Product Code: DSP
• UDI-Device Identifier: 10607567108100
• UDI-Public: 10607567108100
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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-UC-3013-58
• Device Catalogue Number: 0998-UC-3013-58
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1