MAUDE Adverse Event Report: SALTER LABS SLATER LABS; TUBING, OXYGEN, 3-CHANNEL 30'

Model Number 2030-30

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient tripped over the oxygen tubing causing a lump on her head.Although, there was impairment to the body structure, maude report notes no device malfunction.This a user facility reported mdr.Patient tripped over device causing a lump on her head, which caused the patient to seek local care without hospitalization.The oxygen tubing contributed to the injury but did not malfunction.Based on this information this is a reportable event.

Event Description

Patient got her feet tangled in the tubing.

Manufacturer Narrative

Complaint history for this part number was reviewed for the last 24 months.Three similar complaints have been reported but this issue does not appear to be trending.The risk for this failure mode has been mitigated as far as possible.Customer follow up was performed via email.Ra: this failure mode, (r130) tripping due to tubing caught on objects or patient's feet, is identified on the risk analysis file (ra-11) for oxygen cannulas.The severity of harm for this failure mode is extreme (7) and does not meet the threshold for carb review.

Event Description

Patient got her feet tangled in the tubing.

• Brand Name: SLATER LABS
• Type of Device: TUBING, OXYGEN, 3-CHANNEL 30'
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• MDR Report Key: 12095982
• MDR Text Key: 259355208
• Report Number: 3000219639-2021-00015
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2030-30
• Device Catalogue Number: 2030-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other