MAUDE Adverse Event Report: SALTER LABS SALTER LABS; PATIENT KIT - (1) #1215, AND (1) #2025 (AIR LIQUIDE) - 25/CS

Model Number	SO-1188
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Inflammation of the tubing.
Event or Problem Description
Inflammation of the tubing.
Additional 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.

• Brand Name: SALTER LABS
• Common Device Name: 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 Key: 14189567
• Report Number: 3000219639-2022-00022
• Device Sequence Number: 4612932
• Product Code: CAT
• UDI-Device Identifier: 00607411889097
• UDI-Public: 00607411889097
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SO-1188
• Device Catalogue Number: SO-1188
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown