MAUDE Adverse Event Report: COVIDIEN LP PURITAN BENNETT 840; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 4-840120DIUU-US

Device Problem Obstruction of Flow (2423)

Patient Problem Discomfort (2330)

Event Date 01/31/2021

Event Type  malfunction  

Event Description

Ventilator continuously alarmed severe occlusion.Patient was taken off ventilator and manually ventilated.

• Brand Name: PURITAN BENNETT 840
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11420984
• MDR Text Key: 234972620
• Report Number: 11420984
• 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: 03/02/2021,02/01/2021

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: 4-840120DIUU-US
• Device Catalogue Number: 4-840120DIUU-US
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA