MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0576-01

Device Problem Optical Problem (3001)

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

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that after inserting the intra-aortic balloon (iab), the console immediately indicated that there was a fiber optic sensor failure.Troubleshooting was unsuccessful at relieving the sensor failure message.The customer was then advised to transduce the central lumen.This provided a clean, crisp waveform and therapy was continued.The patient was later transferred to another facility.There was no patient harm or adverse event reported.

Manufacturer Narrative

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

Event Description

N/a.

• Brand Name: SENSATION PLUS 8FR. 50CC 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: 12711839
• MDR Text Key: 278789044
• Report Number: 2248146-2021-00708
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 79 KG