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

Model Number 2002-7-50

Device Problem Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/04/2022

Event Type  Injury  

Manufacturer Narrative

Reportable as patients are desaturating while on high flow oxygen devices and cpap devices due to the disconnections.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 304678844
• Report Number: 3000219639-2022-00041
• Device Sequence Number: 1
• Product Code: BYX
• UDI-Device Identifier: 10607411200011
• UDI-Public: 10607411200011
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other