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

Model Number 980

Device Problems No Audible Alarm (1019); Failure to Deliver (2338)

Patient Problem Respiratory Distress (2045)

Event Date 05/23/2019

Event Type  Injury  

Event Description

Pb980 ventilator with patient connected to ventilator stopped ventilating patient.Patient was decompensating while attached to ventilator and had to be removed from device.Ventilator did not self-activate audible alarms as device is set up to do.Visual alarms on control screen showed patient disconnected but did not, ale sound as designed to do.Patient required manual ventilation by staff upon removal of ventilator and device had to be sequestered.Fda safety report id # (b)(4).

• Brand Name: PURITAN BENNETT
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8893603
• MDR Text Key: 154543751
• Report Number: MW5089013
• 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: 08/09/2019

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 Model Number: 980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• 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): Life Threatening
• Patient Age: 64 YR
• Patient Weight: 45