MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; OXYGEN TUBING 7', MCKESSON

Model Number 32647

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

The tubing not attaching would cause an interruption in therapy.If the event were to occur during patient use, they could become hypoxic.

Event Description

Oxygen tubing pulling out of concentrator connector.

Event Description

Oxygen tubing pulling out of concentrator connector.

Manufacturer Narrative

The tubing not attaching would cause an interruption in therapy.If the event were to occur during patient use, they could become hypoxic.The complaint reported that "oxygen tubing pulling out of concentrator connector." the complaint investigation was performed based on the content of the issue reported.Based on the complaint report no patient was affected.The potential root cause may have been due to improper handling of the product.A risk assessment was performed, and the ultimate risk was determined to be low which does not require reporting to the capa review board.This is the first (1) complaint reported for part number 32647 failure mode "disconnecting tube", no other complaints were reported.We will continue to monitor trends during our periodic complaint review meetings.

• Brand Name: WESTMED LLC
• Type of Device: OXYGEN TUBING 7', MCKESSON
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18909185
• MDR Text Key: 337729726
• Report Number: 2028807-2024-00008
• Device Sequence Number: 1
• Product Code: BYX
• UDI-Device Identifier: 20612479203758
• UDI-Public: 20612479203758
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 32647
• Device Catalogue Number: 32647
• Device Lot Number: MWM441358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• 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