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

Model Number 0998-00-3023-55

Device Problem Inability to Auto-Fill (1044)

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

Event Date 04/19/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) displayed autofill failure alarm.There was no harm reported.

Event Description

It was reported that during preventative maintenance by getinge field service engineer, the cs300 intra-aortic balloon pump (iabp) displayed autofill failure alarm.There was no patient involvement.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 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: 19216922
• MDR Text Key: 341478509
• Report Number: 2249723-2024-01785
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• UDI-Public: 10607567112541
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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: Other
• Device Model Number: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Initial Date Manufacturer Received: 04/19/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/07/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1