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

Model Number 0998-00-3023-58

Device Problem Battery Problem (2885)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during routine check, the cs300 intra-aortic balloon pump (iabp) had expired batteries.There was no patient involvement.

Event Description

This report is being cancelled because the batteries were exchanged due to having been expired.There was no malfunction with the iabp.

Manufacturer Narrative

This report is being cancelled because the batteries were exchanged due to having been expired.There was no malfunction with the iabp.Revert all sections to blank : adverse event or product problem suspect medical device initial reporter all manufacturers device manufacturers only.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 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: 18855196
• MDR Text Key: 337371506
• Report Number: 2249723-2024-00959
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108339
• UDI-Public: 10607567108339
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2024

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: 0998-00-3023-58
• Device Catalogue Number: 0998-00-3023-58
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/07/2024; 03/22/2024
• Supplement Dates FDA Received: 03/11/2024; 03/27/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1