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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS SALTER LABS; PATIENT KIT - (1) #1215, AND (1) #2025 (AIR LIQUIDE) - 25/CS
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SALTER LABS SALTER LABS; PATIENT KIT - (1) #1215, AND (1) #2025 (AIR LIQUIDE) - 25/CS Back to Search Results
Model Number SO-1188
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Manufacturer Narrative
The device in question alone does not pose a fire hazard but the use of oxygen increases the risk of fire spreading through an oxygen supply line.The unit in question is expected to melt when exposed to heat.The ignition temperature of pvc is ~851f therefore making it unlikely that the tubing could have spontaneously combusted.Open flames and or ignition sources may include candles, cigarettes, cigars, fire pits, barbeques, etc.Oxygen suppliers are required to provide warnings of fire hazards when oxygen is in use.(i.E., the joint commission, national patient safety goals, 2012).Even though there was no patient injury, oxygen tubing caught on fire due to patient walking with tubing close to the chimney outlet.Based on the information above, this would be a reportable event.
 
Event Description
Inflammation of the tubing.
 
Event Description
Inflammation of the tubing.
 
Manufacturer Narrative
The device in question alone does not pose a fire hazard but the use of oxygen increases the risk of fire spreading through an oxygen supply line.The unit in question is expected to melt when exposed to heat.The ignition temperature of pvc is 851f therefore making it unlikely that the tubing could have spontaneously combusted.Open flames and or ignition sources may include candles, cigarettes, cigars, fire pits, barbeques, etc.Oxygen suppliers are required to provide warnings of fire hazards when oxygen is in use.(i.E., the joint commission, national patient safety goals, 2012).Even though there was no patient injury, oxygen tubing caught on fire due to patient walking with tubing close to the chimney outlet.Based on the information above, this would be a reportable event.A fire event is not related to a device malfunction.The products are performing as expected: a conduit for oxygen delivery.The fire is unrelated to the product itself - it is a by-product of oxygen and an open-source flame (e.G., smoking, candles, sparks from other sources).In this case, there was an ember close to the tubing and was ignited due to the oxygen source.The oxygen has safety requirements displayed and safety signs are provided.No further investigation is required.One other complaint regarding flame has been reported in the last 12 months.Product was replaced.Safety information reviewed with account by oxygen supplier.There was no malfunction of the sunmed product.
 
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Brand Name
SALTER LABS
Type of Device
PATIENT KIT - (1) #1215, AND (1) #2025 (AIR LIQUIDE) - 25/CS
Manufacturer (Section D)
SALTER LABS
30 spur drive
el paso TX 79906
Manufacturer (Section G)
SALTER LABS
30 spur drive
el paso TX 79906
Manufacturer Contact
melissa brickley
2710 northridge dr nw suite a
grand rapids, MI 49544
6162598415
MDR Report Key14189567
MDR Text Key296778255
Report Number3000219639-2022-00022
Device Sequence Number1
Product Code CAT
UDI-Device Identifier00607411889097
UDI-Public00607411889097
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSO-1188
Device Catalogue NumberSO-1188
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
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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