MAUDE Adverse Event Report: SALTER LABS SALTER LABS; TUBING KIT - (1) #1215, (1) #2030 - 25/CS, AIR LIQUIDE

Model Number	SO-1968
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reportable as the patient desaturated.
Event or Problem Description
Very clear cuts located 4 different places on the o2 tubing w/connector  the patient desaturated while plugged into his tank while the saturation was good when plugged into the laptop.The tubing was discovered with very clear cuts of 1 to 2 cm located in 4 different places over the last 2 meters at one end.
Additional Manufacturer Narrative
Reportable as the patient desaturated.Complaint history reviewed.No similar complaints for product under so-1968 or 2030 in the previous 24 months.Without further information, complaint cannot be investigated further.Most likely root cause is product was cut by a sharp object or corner during use.Risk(rma-20017c): r88: low oxygen delivery - tubing breaks or unravels - s=6, o=3, rpn=18.Rpn < 25, therefore risk is acceptable.
Event or Problem Description
Very clear cuts located 4 different places on the o2 tubing w/connector  the patient desaturated while plugged into his tank while the saturation was good when plugged into the laptop.The tubing was discovered with very clear cuts of 1 to 2 cm located in 4 different places over the last 2 meters at one end.

• Brand Name: SALTER LABS
• Common Device Name: TUBING KIT - (1) #1215, (1) #2030 - 25/CS, AIR LIQUIDE
• 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: 17004029
• Report Number: 3000219639-2023-00017
• Device Sequence Number: 15098036
• Product Code: BYX
• UDI-Device Identifier: 00607411918025
• UDI-Public: 00607411918025
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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-1968
• Device Catalogue Number: SO-1968
• Device Lot Number: UNKNOW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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