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

Model Number	0998-00-3013-61
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during repair by getinge field service engineer, the cs100 intra-aortic balloon pump (iabp) unit had console damage.There was no patient involvement.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
There was no patient involvement.It was reported that while replacing a solenoid board of a cs100 intra-aortic balloon pump (iabp), a getinge field service engineer (fse) broke the glass tubing while taking it out.The fse also stated that it was not a component defect but a moment of inattention.
Additional Manufacturer Narrative
In order to fix the issue, the fse replaced the blood detect tubing assembly (b)(6).The fse performed service and functional tests and confirmed that the unit was operational.The unit was then returned to the customer and cleared for clinical use.
Additional Manufacturer Narrative
Ms.(b)(6) is the customer contact.Occupation medical equipment manager, medical equipment department.+(b)(6) , e-mail (b)(6).

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, GERMAN, 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 15520059
• Report Number: 2249723-2022-02421
• Device Sequence Number: 17649540
• Product Code: DSP
• UDI-Device Identifier: 10607567112671
• UDI-Public: 10607567112671
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2023

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: Other
• Device Model Number: 0998-00-3013-61
• Device Catalogue Number: 0998-00-3013-61
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 07/17/2023; 07/19/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 07/18/2023; 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2005
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose