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

Model Number 840

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2015

Event Type  malfunction  

Event Description

Ventilator inop alarm on unstable patient: apparent screen/gui malfunction, so screen was black.Took patient off and used ambu bag to ventilate the patient while the ventilator was taken out of service.The ventilator was taken out of service with circuit intact for biomed troubleshooting.Service request placed.

• 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: 5147791
• MDR Text Key: 28152385
• Report Number: 5147791
• 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
• Report Date: 09/29/2015

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
• Device Model Number: 840
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• 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
• Patient Outcome(s): Other