MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-64
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested, and will be reported accordingly if same becomes available.
Event or Problem Description
It was reported that while connected to a patient, the lines on the screen of the cs100 intra-aortic balloon pump (iabp) made it difficult for the end user to read data.No patient harm, serious injury or adverse event was reported.
Additional Manufacturer Narrative
Device not accessible for testing (4117): at this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event.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 apr 2019 through mar 2021 was reviewed.There were no triggers identified for the review period.A cr/capa/scar/ncmr review was conducted for the two year period apr 2019 through mar 2021.There was capa request identified for the reported failure mode ¿display - blinking, discolored, static, line(s)¿ and product ¿cs100." however, no escalation to capa is required.H3 other text : device not returned to manufacturer.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11589949
• Report Number: 2249723-2021-00663
• Device Sequence Number: 14672990
• Product Code: DSP
• UDI-Device Identifier: 10607567107509
• UDI-Public: 10607567107509
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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: 0998-00-3013-64
• Device Catalogue Number: 0998-00-3013-64
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose