MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, CHINESE,NON-UTS,INTL; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3013-45 - CS100 CHINESE
Medical Device Problem Codes	Device Emits Odor (1425); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Nausea (1970)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to the customer's site.The iabp did not alarm for the malfunction.The fse found that the battery's quality is not good , the electrolyte were leaked.The fse replaced the battery.The fse then completed the full calibration and the iabp passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.Upon completion of our investigation, a supplemental report will be submitted.The full name of the event site noted in (b)(6).
Event or Problem Description
It was reported during the use of cs100 intra-aortic balloon pump (iabp) the user found a pungent and unpleasant odor.The engineer found that the iabp battery electrolyte leaked to produce a pungent odor.No patient injury or harm was reported.However, the odor caused the medical staff to have nausea and headache.Please refer to related mfg report number 2248146-2021-00499 on the involved intra-aortic balloon (iab).
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, g7, h2, h4, h6 (type of investigations, investigation findings, investigation conclusions), h10, h11.Corrected fields: d1, h6 (medical device - problem code).
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, CHINESE,NON-UTS,INTL
• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12312883
• Report Number: 2249723-2021-01781
• Device Sequence Number: 3181697
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0998-UC-3013-45 - CS100 CHINESE
• Device Catalogue Number: 0998-UC-3013-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IAB; IAB
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose