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

Model Number 0998-00-3023-53

Device Problem Unexpected Shutdown (4019)

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

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon receipt of additional information or completion of our investigation.

Event Description

It was reported that while in use the cs300 intra- aortic pump (iabp) shut down for a low battery.The customer reporter that there was no indication that the battery was low.The iabp was restarted on ac power and therapy was able to continue.There was no adverse event reported.

• Brand Name: CS300 ENGLISH
• 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: 14119686
• MDR Text Key: 289359056
• Report Number: 2249723-2022-00876
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2011
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN IAB
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 67 KG