MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 840

Device Problems Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The replaced inspiratory module was returned for failure investigation.Upon receipt a visual inspection revealed that the module was returned without the water trap and the 02 sensor was broken.The unit was severely damaged with liquid contamination.There were splash marks evident on the module.When disassembling the unit to remove the air flow sensor for inspection liquid spilled out onto the working surface.Once the flow sensor was removed it was noted that the port into which the flow sensor tubing is seated was full of water.Because of the extensive damage and contamination, it would not be safe to attach the returned inspiratory module and power on the ventilator.The preventative maintenance section of the 840 operators and technical reference manual gives instructions on preventative maintenance procedures and frequency for expiratory and inspiratory limbs, bacteria filters, water traps and drain bags.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the pb840 ventilator's inspiratory module was "inoperative".There was water inside the flow sensors and psol's (proportional solenoid valve).The ventilator was not in use on a patient at the time of the reported event.

Manufacturer Narrative

Unique identifier (udi) number added to section d.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 840 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; michael collins road mervue; galway
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; michael collins road mervue; galway
• Manufacturer Contact: kelly adams ; 2101 faraday ave; carlasbad, CA 92008 ; 7606035046
• MDR Report Key: 7316533
• MDR Text Key: 101623135
• Report Number: 8020893-2018-00116
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• 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: 10049998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2011
• 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