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

Model Number 2002-7-50

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

Could cause an interruption in therapy and hypoxia.

Event Description

Can't keep tubing attached to oxygen bleed in stem for adding oxygen to circuits providing positive pressure.

Event Description

Can't keep tubing attached to oxygen bleed in stem for adding oxygen to circuits providing positive pressure.

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
• Type of Device: 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
• MDR Text Key: 337001867
• Report Number: 3000219639-2024-00022
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other