MAUDE Adverse Event Report: SALTER LABS SALTER LABS OXYGEN TUBING

Model Number 2025G

Device Problem Human Factors Issue (2948)

Patient Problem Death (1802)

Event Date 11/09/2016

Event Type  Death  

Manufacturer Narrative

This is the initial and final report.This is a companion report to user report 361562-2016-0004.Patient has multiple concurrent medical conditions.Event includes fracture and hematoma, although the patient's medical condition includes degenerative bone disease.Because of the degenerative bone disease, it cannot be definitively stated that the patients fall led to the fractures.Patient was admitted to the hospital.During the hospital stay, the pleural effusion increased.Patient subsequently expired on (b)(6)2016.Cause of death not provided.

Event Description

This is the initial and final report.This is a companion report to user report 361562-2016-0004.Distributor reports that the patient stated she had tripped over oxygen tubing and fell, sustaining injuries including fractured vertebra and hematoma.Patient reported multipel concurrent preexisting medical conditions including heart failure, hypertension, atrial fibrillation, dresslers syndrome, osteoprosis, coronary artery disease, pleural effusion, rheumatoid arthritis and ischemic cardiomyopathy.

• Brand Name: SALTER LABS OXYGEN TUBING
• Type of Device: OXYGEN 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: 6182966
• MDR Text Key: 62637840
• Report Number: 3000219639-2016-00012
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2025G
• Device Catalogue Number: 2025G
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death