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

Model Number	0998-UC-3013-68
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replaced the system motherboard and the solenoid control plate.The iabp has not been returned to the customer and cleared for clinical use at this time.(b)(6).
Event or Problem Description
It was reported that after performing service, the getinge service territory manager (stm) noted the cs100 intra-aortic balloon pump (iabp) had expired batteries and safety disk.There was no patient involvement, and no adverse event reported.
Event or Problem Description
It was reported that after performing service, the getinge service territory manager (stm) noted the cs100 intra-aortic balloon pump (iabp) had expired batteries and safety disk.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, d4(version or model #), g3, g6, h2, h6, h10.A getinge service representative reported that additional information was requested from the customer with regard to the status of the iabp.The customer reported that the iabp was not put in clinical use after the getinge service as mentioned in the initial emdr.The iabp is not to be released for clinical use until the indicated parts are replaced.A budget for the purchase of the parts was sent to the customer, but the customer has not approved it yet, and is unknown as to when it will be approved.If any pertinent information is received in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
An initial emdr for this complaint was incorrectly submitted.Additional information has been received clarifying that no malfunction occurred and a complaint was incorrectly submitted for a routine preventative maintenance.As a result, no follow up emdr is necessary, as the complaint will be cancelled in our database.Please cancel in your database.
Event or Problem Description
N/a.

• Brand Name: CS100
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 10701175
• Report Number: 2249723-2020-01716
• Device Sequence Number: 11500578
• Product Code: DSP
• UDI-Device Identifier: 10607567108698
• UDI-Public: 10607567108698
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2022

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: Other
• Device Model Number: 0998-UC-3013-68
• Device Catalogue Number: 0998-UC-3013-68
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 05/24/2021; 05/20/2022
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 05/26/2021; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown