MAUDE Adverse Event Report: CAREFUSION 2200, INC. AIRLIFE; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Catalog Number 2K8018

Device Problems Inadequacy of Device Shape and/or Size (1583); Failure to Disconnect (2541)

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

Event Date 01/31/2017

Event Type  malfunction  

Event Description

The patient had a desaturation episode to the 60's during a treatment.The respiratory therapist went to use the resuscitation bag and mask, but the mask size was wrong and they were not able to disconnect the mask from bag to switch to a different size.

• Brand Name: AIRLIFE
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 6398586
• MDR Text Key: 69758851
• Report Number: 6398586
• Device Sequence Number: 1
• Product Code: BTM
• 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: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2K8018
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2017
• 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