MAUDE Adverse Event Report: MEDTRONIC (COVIDIEN LP) PURITAN BENNETT; VENTILATOR

Model Number PB 980

Device Problem Ventilation Problem in Device Environment (3027)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 06/26/2018

Event Type  malfunction  

Event Description

Patient was on vent being suctioned and vent started alarming and quit ventilating the patient.Quick assessment done showing that vent couldn't be fixed so patient was taken off ventilator and bagged.Another respiratory therapist went and got a new vent to place patient on.Patient did desaturate to 86% while switching from vent to bag, recovered quickly.No issues with new vent.

• Brand Name: PURITAN BENNETT
• Type of Device: VENTILATOR
• Manufacturer (Section D): MEDTRONIC (COVIDIEN LP); 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7772217
• MDR Text Key: 116748474
• Report Number: 7772217
• 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: 07/26/2018,07/17/2018

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: PB 980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25550 DA
• Patient Weight: 124