MAUDE Adverse Event Report: SALTER LABS SALTER LABS OXYGEN TUBING

Model Number 2025G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Patient Problem/Medical Problem (2688)

Event Date 06/26/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Initial report found during review of maude database.Per initial report, no malfunction.Lot number not provided; initial reporter information not provided, further investigation is not possible.Not previously reported to salter labs.This is the initial and final report.

Event Description

Companion report to (b)(4).The patient was being assisted to the bathroom by an aide who tripped over the tubing, causing the patient to also fall.Injury reported (hip fracture).Patient was treated at hospital for pain only per family request, and subsequently died.No device malfunction reported.

• 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 ; 236 camino vida roble; carlsbad, CA 92011 ; 7607957094
• MDR Report Key: 7355976
• MDR Text Key: 102996124
• Report Number: 3000219639-2018-00003
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Home Health Aide
• Device Model Number: 2025G
• Device Catalogue Number: 2025G
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Death