MAUDE Adverse Event Report: SALTER LABS SALTER LABS; TUBING, OXYGEN, 3-CHANNEL 7' - 50/CS

Model Number	2002-7-50
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reportable as patients are desaturating while on high flow oxygen devices and cpap devices due to the disconnections.
Event or Problem Description
The connectors tend to slip and become disconnected easily.Patients are having desaturations while on high flow oxygen devices and cpap devices due to the disconnection.
Event or Problem Description
The connectors tend to slip and become disconnected easily.Patients are having desaturations while on high flow oxygen devices and cpap devices due to the disconnection.
Additional Manufacturer Narrative
Reportable as patients are desaturating while on high flow oxygen devices and cpap devices due to the disconnections.Complaint history reviewed.There have been no other complaints for tubing coming off of oxygen source in the previous 24 months.Issue is not trending.Root cause determined to be customer using tubing outside of the intended use range, at a flow rate 3-4 times higher than the maximum recommended.Risk(rma-20017c): r34: tubing disconnects from oxygen source - tubing connected to excessive flow rate oxygen source - s=6 o=1, rpn=6.Rpn < 25, therefore risk is acceptable.

• Brand Name: SALTER LABS
• Common Device Name: TUBING, OXYGEN, 3-CHANNEL 7' - 50/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: 15900753
• Report Number: 3000219639-2022-00041
• Device Sequence Number: 20108601
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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: 2002-7-50
• Device Catalogue Number: 2002-7-50
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown