MAUDE Adverse Event Report: COVIDIEN PURITAN BENNETT VENTILATOR

Model Number 980

Device Problems Tidal Volume Fluctuations (1634); Improper Device Output (2953)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 02/16/2018

Event Type  Injury  

Event Description

Patient was on ventilator approximately 5 days and suddenly began to display tidal volumes in excess of 2 liters.Upon inspection of the ventilator, the numerical display showed the vte at 2377 mls and the vetotal at 56.3 liters while the vt graphic waveform showed volumes at approximately 300 - 400 mls.This is a major discrepancy.Upon assessing the patient, she was comfortable and was nowhere near breathing at a minute ventilation of 56 liters.The ventilator was changed out and the new ventilator displayed volumes of 400 ml.

• Brand Name: PURITAN BENNETT VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 7320674
• MDR Text Key: 101894239
• Report Number: MW5075732
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 62