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

Model Number SO-1968

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

Reportable as the patient desaturated.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 315947835
• Report Number: 3000219639-2023-00017
• Device Sequence Number: 1
• Product Code: BYX
• UDI-Device Identifier: 00607411918025
• UDI-Public: 00607411918025
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SO-1968
• Device Catalogue Number: SO-1968
• Device Lot Number: UNKNOW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other