MAUDE Adverse Event Report: COVIDIEN LP PURITAN BENNETT 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 980

Device Problem Defective Device (2588)

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

Event Date 11/15/2020

Event Type  malfunction  

Event Description

Ventilator went into backup ventilation mode which runs on apnea settings.The vent posted error codes associated with inspiratory pressures.The ventilator was pulled out of service and a service call was placed to medtronic.The ventilator has 191 hours of use and was new since july 2020.

• Brand Name: PURITAN BENNETT 980 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10918970
• MDR Text Key: 218674248
• Report Number: 10918970
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/23/2020

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
• Device Model Number: 980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2020
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Weight: 97