MAUDE Adverse Event Report: COVIDIEN LP PURITAN BENNETT; VENTILATOR, CONTINUOUS, FACILITY USE

Device Problems Poor Quality Image (1408); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2019

Event Type  malfunction  

Event Description

Rental ventilator had gui malfunction.Lower half of interface became white and pixelated, making vent/alarm changes impossible, as well as not being able to see what current vent settings are.Patient was still being ventilated, and could be assessed as such due to top half of the screen and graphics still visible.Rt swapped with a functioning ventilator.Patient had no deterioration during any portion of the process.Faulty equipment is currently removed from service, and due to it being a rental, has been cleaned.Sent back to rental company.

• Brand Name: PURITAN BENNETT
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8711694
• MDR Text Key: 148441044
• Report Number: 8711694
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29200 DA