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

Catalog Number	0998-UC-3013-45
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested, and we will report accordingly if it becomes available.(b)(6).
Event or Problem Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) alarmed and the iabp loop leaked air.The customer stopped using the cs100 immediately with no affect to the patient.No patient harm, serious injury or adverse event was reported.
Additional Manufacturer Narrative
A getinge authorized distributor's field service engineer (fse) evaluated the iabp unit and replaced the safety disk to fix the reported issue.The iabp was then released to the customer and cleared for clinical service.
Event or Problem Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) alarmed and the iabp loop leaked air.The customer stopped using the cs100 immediately with no affect to the patient.No patient harm, serious injury or adverse event was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Analysis of production: (3331/213) 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.Historical data analysis: (4109/213) 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: (4110/213) the overall 12 month product complaint trend data for the period (feb-2020 through jan-2021) was reviewed.There were no triggers identified for the review period.

• 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: 11215976
• Report Number: 2249723-2021-00135
• Device Sequence Number: 11655454
• Product Code: DSP
• UDI-Device Identifier: 10607567111957
• UDI-Public: 10607567111957
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2021

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: Health Professional
• Device Catalogue Number: 0998-UC-3013-45
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 02/19/2021; 06/25/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 03/17/2021; 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1