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
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had a loop air leakage fault.There was no patient harm reported.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.Due to character limitations the initial reporter name and address: (tel #): (b)(6).
Additional Manufacturer Narrative
A getinge representative was not dispatched to evaluate the iabp unit because the hospital does its own repairs and does not need to go to the scene in person.It was detected that the fault was caused by the damage of the safety disk.Clinical customers have been clearly informed that they cannot be used on patients, and the machine can only be officially used after replacing the safety disc.The clinical client decided that the price of the safety disk was too high, so they did not replace it with a brand new safety disk.After the equipment department repaired it by itself (getinge representative also told that all the machines that have not been repaired by the manufacturer cannot be used clinically), the equipment department felt that there was no problem with the machine.Continue to use.As a result, the device alarms during use and causes adverse events, and then the extubation and machine removal are suspended.It has been repaired and has been used clinically.The serial number cannot be seen clearly because the sticker recording the serial number of the unit is damaged, therefore cannot be provided.The hospital is unwilling to disclose more information.
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: 16014087
• Report Number: 2249723-2022-03213
• Device Sequence Number: 15287423
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 07/16/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown