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

Model Number 0998-00-3023-45

Device Problem Failure to Power Up (1476)

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

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

Due to character restrictions in block e1 telephone number : (b)(6).A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during routine inspection, the cs300 intra-aortic balloon pump (iabp) could not be turned on, immediately the equipment was no longer used.There were no causalities reported.

Manufacturer Narrative

A getinge field service engineer evaluated unit.The device cannot be turned on, re-plug and unplug the motherboard cable and reinstall the motherboard.The fault disappears.The equipment has passed all performance and safety tests specified by the factory.The machine performs normally and is delivered to the customer for normal use.

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V
• 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: 18498135
• MDR Text Key: 332919720
• Report Number: 2249723-2024-00105
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108575
• UDI-Public: 10607567108575
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-45
• Device Catalogue Number: 0998-00-3023-45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1