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 No Device Output (1435)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2023

Event Type  malfunction  

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) printer not working.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected data: b5, b6, b7, d5, d10, e4, g2, h6 (clinical and impact code).Updated data: b3, b4, e1 (initial reporter and email), e2, e3, g3, g6, h2, h10, h11.

Event Description

It was reported that during preventative maintenance by getinge field service engineer, the cs300 intra-aortic balloon pump (iabp) printer not working.There was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that after replacement of recorder and pcb recorder interface the issue was resolved.The unit was given to customer having passed all functional and safety tests.

• 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: 17867882
• MDR Text Key: 324878521
• Report Number: 2249723-2023-04323
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2024

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: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 10/05/2023; 02/05/2024
• Supplement Dates FDA Received: 10/09/2023; 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.