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

Model Number 840

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/03/2021

Event Type  malfunction  

Event Description

Patient had a sudden drop in his oxygen saturations.When this rt came on shift she was called to change out ventilator by residents.They were concerned that the ventilator old and not working properly and they had ran out of ideas why patient was no longer maintaining o2 stats.The ventilator was changed to a newer model (980) and o2 stats did improve, however prior to placing patient on the new ventilator, patient was manually ventilated until new ventilator was placed on patient.Manufacturer response for ventilator, covidien (per site reporter).Machine was brought down to the shop.Checked ventilator settings.Patient was on 100% o2 in a/c mode with vc+.Checked the alarms logs and didn't see any equipment alarms.Went into service diagnostics and ran est.When the unit was running the flow sensor test i noticed the expiratory flow sensor (q3) was reading lower than what the o2 flow sensor (q1) was reading.The air flow sensor (q2) was reading close to what the expiratory flow sensor (q3) was reading.Recalibrated the flow sensors and ran est again.The flow reading was still reading low but passing.This leads me to believe q1 is going bad.Will order a replacement flow sensor through parts source.Contacted covidien and opened up a product complaint.Provided them information that i know about the incident and the equipment.They will reach out to answer any further clinical questions.Received a questionnaire from covidien and will complete it.Replaced the o2 flow sensor.Calibrations, testing, and pvt will be performed tomorrow.Performed all calibrations and testing per table 5-2 of the service manual.Unit passed.Documentation attached to work order.Returned for service.

• Brand Name: PURITAN BENNETT
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11588623
• MDR Text Key: 242920008
• Report Number: 11588623
• 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: 03/10/2021,03/03/2021

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: No Information
• Device Model Number: 840
• 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: 03/10/2021
• Date Report to Manufacturer: 03/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1