MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-61
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) the cs300 intra-aortic balloon pump (iabp) the device failed the battery test, the batteries did not reach the required minimum runtime and the device switched off after around 98 minutes.There was no patient involvement.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate the issue.The fse stated that according to the user, the unit was used properly up to that point, and that the user has been instructed in the operation of the unit and that the unit has been in use there for years.After approval, the fse replaced the two batteries.Then, a complete device check was carried out as part of the maintenance.

• Brand Name: CS300 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: 16868754
• Report Number: 2249723-2023-02231
• Device Sequence Number: 6090122
• Product Code: DSP
• UDI-Device Identifier: 10607567108278
• UDI-Public: 10607567108278
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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: 0998-00-3023-61
• Device Catalogue Number: 0998-00-3023-61
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2008
• 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: N/A.
• Patient Sex: Unknown