MAUDE Adverse Event Report: SALTER LABS SALTER LABS; TUBING, OXYGEN, 3-CHANNEL 7'

Model Number	2002-7-50
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Could cause an interruption in therapy and hypoxia.
Event or Problem Description
Can't keep tubing attached to oxygen bleed in stem for adding oxygen to circuits providing positive pressure.
Event or Problem Description
Can't keep tubing attached to oxygen bleed in stem for adding oxygen to circuits providing positive pressure.
Additional Manufacturer Narrative
Could cause an interruption in therapy and hypoxia.The issue described in the customer complaint most closely aligns with risk id "r5" a potential cause of hazard being " disconnect/unable to connect to o2 source " severity = 8/10, occurrence = 2, therefore rpn = 16 per rma-20017c rev 7-oxygen tubing and accessories product risk analysis.Given the complaint history review, there was one complaint about a similar issue reported in the 24 months that preceded the complaint report date.Per table 1a of the risk determination chart (ref-20001-c1 rev 1), a severity rating of 8/10 (serious) and an occurrence level of "improbable" results in a "low" risk with a "capa optional".Therefore, no capa is required.Reviewed sop-20021-c1 rev 1 in order to determine if an hhe was triggered.None of the triggers listed applied to this complaint.Therefore, an hhe is not required.

• Brand Name: SALTER LABS
• Common Device Name: TUBING, OXYGEN, 3-CHANNEL 7'
• 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: 18773723
• Report Number: 3000219639-2024-00022
• Device Sequence Number: 18077368
• Product Code: BYX
• UDI-Device Identifier: 10607411200011
• UDI-Public: 10607411200011
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2002-7-50
• Device Catalogue Number: 2002-7-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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