MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2023

Event Type  malfunction  

Event Description

It was reported during a routine check the cs300 intra-aortic balloon pump (iabp) unit battery failed after 20-30 minutes.There was no patient involvement reported.

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

A getinge field service engineer (fse) performed battery run test and observed cs300 batteries failed @58 minutes.Replaced defective batteries and corrected customer failure.Unit passed all functional and safety tests per factory specifications, returned to customer.The defective components were received for further investigation.Please refer to the root cause evaluation field for details.The failure analysis and testing dept.Received (2) part number 0146-00-0039 with a reported unit failure of a failed battery runtime test at 52 minutes.The fat performed a visual inspection and found the part to be in good condition.The fat installed the parts into cs300 test fixture serial number si206230b5 and tested the part to factory specifications per procedure number 0002-07-d016 revision e and the cs300 service manual part number 0070-00-0689 rev w.The battery runtime test failed at 54 minutes.Fat was able to verify the reported issue.Retaining the part in the failure analysis and testing department per procedure number 0002-07-d008 rev.Ap.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• Type of Device: 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: 17714127
• MDR Text Key: 323000450
• Report Number: 2249723-2023-04003
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1