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

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 10/03/2023

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) unit has intermittent display.There was no patient involvement reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate.They arrived onsite and confirmed the screen would have multiple lines throughout the screen.The fse removed and replaced the display as required.The repair was completed with all functional and safety tests per manufacturer specifications.

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) unit has intermittent display.There was no patient involvement reported.The biomed verified that the screen would have multiple lines throughout the screen.

• 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: 17905892
• MDR Text Key: 325299597
• Report Number: 2249723-2023-04387
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/1999
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1