MAUDE Adverse Event Report: COVIDIEN LLC PURITAN BENNETT; ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Respiratory Distress (2045); No Code Available (3191)

Event Date 09/29/2015

Event Type  malfunction  

Event Description

Patient went to have to ct scan from er.The patient was manually ventilated to ct scan.Brought 840, set up 840 and put patient on vent.After ct scan was done, the patient coded and we started manually ventilating the patient.Got pulse back and returned to room and when respiratory therapist went to turn on the vent in room 8, it said ventilator malfunction.Kept manually ventilating patient until new vent was brought to room.

• Brand Name: PURITAN BENNETT
• Type of Device: ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield, MA 02048
• MDR Report Key: 5191040
• MDR Text Key: 29929492
• Report Number: 5191040
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS
• Patient Age: 42 YR