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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS SALTER; TUBING, OXYGEN, 3-CHANNEL 30'
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SALTER LABS SALTER; TUBING, OXYGEN, 3-CHANNEL 30' Back to Search Results
Model Number 2030-30
Device Problems Material Twisted/Bent (2981); Positioning Problem (3009)
Patient Problem Fall (1848)
Event Date 11/12/2020
Event Type  Injury  
Manufacturer Narrative
It was reported that the patient tripped over the oxygen tubing causing injury to their forearm.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 injury to forearm, which caused a smoothing/flattening of the skin, over 10cm long and 1.5cm wide.The wound required home care (cleaning, disinfection, bandaging) for 10 days.The oxygen tubing contributed to the injury but did not malfunction.Based on this information this is a reportable event.
 
Event Description
The tubing twisted around the patient's foot while she was sitting.The patient stood up to go into another room, the tubing got stuck under the chair and the patient fell from her height.
 
Manufacturer Narrative
It was reported that the patient tripped over the oxygen tubing causing injury to their forearm.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 injury to forearm, which caused a smoothing/flattening of the skin, over 10cm long and 1.5cm wide.The wound required home care (cleaning, disinfection, bandaging) for 10 days.The oxygen tubing contributed to the injury but did not malfunction.Based on this information this is a reportable event.A formal investigation of this complaint is unnecessary.This is a known failure mode and the risk can be reduced by avoiding incorrect use, using the shortest tubing possible, and using caution around tripping hazards.This risk has been reduced as far as possible and the benefit of this product outweighs the risk.Complaint history for this part number was reviewed for the last 24 months.Two (2) similar complaints have been reported, but this issue does not appear to be trending at this time.Complaints of this nature will continue to be monitored for trending.The customer was given suggestions for how to reduce the risk of this issue in a follow up email.
 
Event Description
The tubing twisted around the patient's foot while she was sitting.The patient stood up to go into another room, the tubing got stuck under the chair and the patient fell from her height.
 
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Brand Name
SALTER
Type of Device
TUBING, OXYGEN, 3-CHANNEL 30'
Manufacturer (Section D)
SALTER LABS
30 spur drive
el paso TX 79906
MDR Report Key11631526
MDR Text Key244366453
Report Number3000219639-2021-00003
Device Sequence Number1
Product Code BYX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number2030-30
Device Catalogue Number2030-30
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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