MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number 30002426540003

Device Problem Defective Device (2588)

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

Event Date 10/21/2022

Event Type  malfunction  

Event Description

Iabp with optical sensor failure alarm, troubleshooting unsuccessful to resolve alarm.Getinge technical support notified, no additional troubleshooting options or solutions presented.Iabp continues to run normally.No precipitating factors identified prior to sensor failure alarm.Per getinge clinical support, they would like to have this balloon sent back to company for further evaluation / diagnostics.

• Brand Name: SENSATION PLUS 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 16014389
• MDR Text Key: 305874796
• Report Number: 16014389
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/28/2022

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 Lot Number: 30002426540003
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Sex: Male