MAUDE Adverse Event Report: SALTER LABS MALLINCKRODT NEBULIZER WITH ADULT AEROSOL MASK

Model Number 13962

Device Problem Installation-Related Problem (2965)

Patient Problem Death (1802)

Event Type  Death  

Event Description

On (b)(6) 2014 salter labs was informed of an incident of device model number 13962, mallinckrodt nebulizer with adult aerosol mask 2.1 m supply tube, elastic strap fixation, universal connector.

• Brand Name: MALLINCKRODT NEBULIZER WITH ADULT AEROSOL MASK
• Type of Device: MALLINCKRODT NEBULIZER
• Manufacturer (Section D): SALTER LABS; 2365 camino vida roble; carlsbad CA 92011 000
• Manufacturer Contact: aurelia brownridge ; 2365 camino vida roble; carlsbad, CA 92011-0000 ; 7607957102
• MDR Report Key: 4199224
• MDR Text Key: 4961549
• Report Number: 3000219639-2014-00009
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 13962
• Device Catalogue Number: 13962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death