MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0470-01

Device Problems Optical Problem (3001); Pressure Problem (3012)

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

Event Date 06/12/2023

Event Type  malfunction  

Manufacturer Narrative

Occupation: manager cvicu the device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).Device not returned.

Event Description

It was reported that during intra-aortic balloon (iab) therapy the console generated a fiber optic sensor failure alarm and an unable to update timing alarm.The customer noted they did not have an arterial line.The monitor displayed "source: transducer" though a fiberoptic iab was being used.The customer was directed to remove and reinsert the fiberoptic sensor with the red triangles lined up.They said they heard it click, but the issue did not resolve.They stated they did have a pressure bag hooked to the inner lumen, however, there was no grey pressure cable available nor was there one on another console they had.The patient was be going to the cvor that day.There was no patient harm or adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Additional reporter: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).

• Brand Name: SENSATION 7FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 17227725
• MDR Text Key: 318120875
• Report Number: 2248146-2023-00416
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: 10607567106779
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000287426
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN PUMP
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 76 KG