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

Model Number 840

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the ventilator went into occlusion.Patient involvement information was not provided by the customer.

• Brand Name: PURITAN BENNETT
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway
• Manufacturer Contact: ray maroofian ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6350208
• MDR Text Key: 68085271
• Report Number: 8020893-2017-05018
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K970460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2017

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: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 4-840220DIUA-EN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1