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

Model Number	0998-UC-3013-45
Medical Device Problem Codes	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing of actual/suspected device: a getinge field service engineer (fse) evaluated the iabp and after detection of the reported issue, the fse judged that the safety disk was faulty.After replacing the safety disk, the iabp was normal.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) alarmed "iab loop air leak".No patient harm, serious injury or adverse event was reported.
Additional Manufacturer Narrative
The alarm mentioned in the event description (b5) of the initial emdr was incorrect.The correct alarm was "leak in iab circuit".Analysis of production: (3331) the device history record 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) 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) the overall 24 month product complaint trend data for the period aug-2019 through jul-2021 was reviewed.There were no triggers identified for the review period.
Event or Problem Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) alarmed "leak in iab circuit".No patient harm, serious injury or adverse event was reported.

• Brand Name: CS100
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• MDR Report Key: 12267412
• Report Number: 2249723-2021-01688
• Device Sequence Number: 4376652
• 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
• Report Date (Section B): 10/15/2021

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 Model Number: 0998-UC-3013-45
• Device Catalogue Number: 0998-UC-3013-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/18/2021
• Patient Sequence Number: 1