MAUDE Adverse Event Report: SALTER LABS SALTER LABS TUBING; SUPPLY TUBING

Model Number 2525-25

Device Problem Device Issue (2379)

Patient Problem Hypoxia (1918)

Event Date 09/30/2016

Event Type  malfunction  

Event Description

Patient reports that the oxygen supply tubing kinked and caused desaturation.Total length of tubing + cannula is 57 feet.Patient reports that this event has occurred with other tubing from other vendors.No other injury reported.

• Brand Name: SALTER LABS TUBING
• Type of Device: SUPPLY TUBING
• Manufacturer (Section D): SALTER LABS; 2365 camino vida roble; carlsbad CA 92011
• Manufacturer (Section G): SALTER LABS; 2365 camino vida roble; carlsbad CA 92011
• Manufacturer Contact: mara caler ; 2365 camino vida roble; carlsbad, CA 92011 ; 7607957094
• MDR Report Key: 6028829
• MDR Text Key: 57623624
• Report Number: 3000219639-2016-00010
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2525-25
• Device Catalogue Number: 2525-25
• Device Lot Number: NOP101915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1