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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS SALTER LABS; TUBING KIT - (1) #1215, (1) #2030 - 25/CS, AIR LIQUIDE
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SALTER LABS SALTER LABS; TUBING KIT - (1) #1215, (1) #2030 - 25/CS, AIR LIQUIDE Back to Search Results
Catalog Number SO-1968
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 01/10/2022
Event Type  Injury  
Event Description
The incident as recorded within our customer complaint handling system states the following: "patient tripped over cannula".
 
Manufacturer Narrative
It was reported that the patient tripped over the oxygen tubing but no reported injury to patient.This a user facility reported mdr.Patient tripped over device.The oxygen tubing contributed may have contributed to an injury but did not malfunction.Based on this information this is a reportable event.
 
Event Description
The incident as recorded within our customer complaint handling system states the following: "patient tripped over cannula".
 
Manufacturer Narrative
It was reported that the patient tripped over the oxygen tubing but no reported injury to patient.This a user facility reported mdr.Patient tripped over device.The oxygen tubing contributed may have contributed to an injury but did not malfunction.Based on this information this is a reportable event complaint history for tripping complaints reviewed for the last 24 months.One similar complaint 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 per (b)(4): "otc ifu recommends the use of a swivel connector to reduce the possibility of twisting for o2 cannulas + tubing systems longer than 14 ft." this reduces the risk as far as possible.Device malfunction can not be blamed for the cause of complaint.Risk id: r90: tripping where harm: minor injury from fall has a severity of (7) and with rc7 implemented has an occurrence of (2) for an rpn of (14) which is an acceptable amount of risk.
 
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Brand Name
SALTER LABS
Type of Device
TUBING KIT - (1) #1215, (1) #2030 - 25/CS, AIR LIQUIDE
Manufacturer (Section D)
SALTER LABS
30 spur drive
el paso TX 79906
Manufacturer (Section G)
SALTER LABS
2710 northridge dr nw suite a
grand rapids MI 49544
Manufacturer Contact
melissa brickley
2710 northridge dr nw suite a
grand rapids, MI 49544
6162598415
MDR Report Key13373096
MDR Text Key284613790
Report Number3000219639-2022-00004
Device Sequence Number1
Product Code BYX
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue NumberSO-1968
Device Lot Number117964
Was Device Available for Evaluation? No
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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