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

Model Number	0998-00-3013-65
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The name of the initial reporter is unavailable, at this time.A supplemental report will be submitted when additional information is provided.
Event or Problem Description
It was reported that during a cardiac surgical procedure, the cs100 intra-aortic balloon pump (iabp) shutdown.It was also reported that the user restarted the unit and was able to use it safely.Further, the machine was changed at 15:00 hours to see what was important.No patient harm, serious injury, or adverse event was reported.
Event or Problem Description
It was reported that during a cardiac surgical procedure, the cs100 intra-aortic balloon pump (iabp) shutdown.It was also reported that the user restarted the unit and was able to use it safely.Further, the machine was changed at 15:00 hours to see what was important.No patient harm, serious injury or adverse event was reported.
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.Cleaning was performed inside the console and the connecting part.Routine preventive maintenance (pm) was performed and the pneu luer, safety disk, and battery were replaced as part of the pm.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.
Additional Manufacturer Narrative
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 (dec 2019 through nov 2020) was reviewed.There were no triggers identified for the review period.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.

• 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: 11008023
• Report Number: 2249723-2020-02148
• Device Sequence Number: 4496208
• Product Code: DSP
• UDI-Device Identifier: 10607567108674
• UDI-Public: 10607567108674
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2021

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: 0998-00-3013-65
• Device Catalogue Number: 0998-00-3013-65
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 03/12/2021; 07/27/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 04/09/2021; 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: YMT40R-01 LOT,3000115900
• Patient Age: 67 YR
• Patient Weight: 65