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

Catalog Number 0998-UC-3013-55

Device Problem Pressure Problem (3012)

Patient Problems No Patient Involvement (2645); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested, and we will report accordingly if it becomes available.

Event Description

It was reported that prior to use the cs100 intra-aortic balloon pump (iabp) did not show the blood pressure rise.The pressure cable broken, causing the blood pressure signal to not rise.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6, h10, h11.Corrected fields: h3, h6(evaluation method codes), h10.A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.It was found that the "pressure cable" was damaged, causing the pressure signal not to be replaced.The fse used a secondary pressure cable to test the iabp, and the iabp worked normally.This spare part must be replaced before the iabp could be used clinically.A quotation was submitted to the customer for approval of the repairs; however, the quotation has not been approved yet, and it is unknown as to when it will be approved.If any pertinent information is received in the future, a supplemental report will be submitted.

Event Description

It was reported that prior to use, the cs100 intra-aortic balloon pump (iabp) did not show the blood pressure rise.The pressure cable broken, causing the blood pressure signal to not rise.There was no patient involvement, and no adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h4, h6 (type of investigation), (component codes), (health effect-impact codes), h10.Analysis of production: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/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.Historical data analysis: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) the overall 24 month product complaint trend data for the period (jan-2020 through dec-2020 ) was reviewed.There were no triggers identified for the review period.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11141267
• MDR Text Key: 225822463
• Report Number: 2249723-2021-00020
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107875
• UDI-Public: 10607567107875
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 0998-UC-3013-55
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 01/25/2021; 06/21/2021
• Supplement Dates FDA Received: 02/19/2021; 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1