MAUDE Adverse Event Report: SALTER LABS SALTER LABS SAFETY PEP; SALTER SAFETY PEP

Model Number 1301

Device Problem Misassembly by Users (3133)

Patient Problem Visual Disturbances (2140)

Event Date 12/26/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, salter labs received a complaint from one of our customers stating that below: on (b)(6) 2014, while the patient was receiving a nebu-pep treatment the pressure relief valve cap went off into the patient's mouth and airway.The patient was able to get the device out, but he was frightened.The patient was changed to an ez-pap device because the patient didn't want to continue using the nebu-pep.The device was not returned to the manufacturer.The customer threw away the device.

• Brand Name: SALTER LABS SAFETY PEP
• Type of Device: SALTER SAFETY PEP
• Manufacturer (Section D): SALTER LABS; 2365 camino vida roble; carlsbad CA 92011
• Manufacturer Contact: aurelia brownridge ; 2365 camino vida roble; carlsbad, CA 92011 ; 7607957102
• MDR Report Key: 4459653
• MDR Text Key: 5397425
• Report Number: 3000219639-2015-00001
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1301
• Device Catalogue Number: 1301-0-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other