MAUDE Adverse Event Report: SALTER LABS SALTER LABS; HUMIDIFIER, BUBBLE, W/ 6 PSI SAFETY VALVE -

Model Number 7900-0

Device Problems Crack (1135); Defective Device (2588)

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

Event Date 02/28/2022

Event Type  malfunction  

Event Description

Defective bubble humidifiers cracked vertically.

Manufacturer Narrative

An interruption in delivery of oxygen to patient, which has a potential to lead to hypoxia.Based on the reported information, the criteria for reporting an adverse event have been met.

Event Description

Humidifier causing oxygen to not flow through oxygen concentrator.Home user lost oxygen flow from concentrator and his spouse had to replace the unit.

Manufacturer Narrative

Complaint history reviewed for the past 24months checked for 7900-0 pn.There is 1 similar complaint that was deemed user error.This issue is not trending, however will continue to be monitored.Device was checked for any occlusions or blockage in the tubing or lid - nothing is blocking the air pathway.Device underwent testing via wi-10009 - and passed.Upon further evaluation it was discovered most likely cause of failure was improper sealing of humidifier.Video detailing method and proper installation technique sent to customer.Risk(rma-20015a): r35: low o2 delivery due to user does not install humidifier cover correctly.S=8, o=2, rpn = 16 rpn < 25 and therefore is acceptable.

• Brand Name: SALTER LABS
• Type of Device: HUMIDIFIER, BUBBLE, W/ 6 PSI SAFETY VALVE -
• 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: 13889448
• MDR Text Key: 296777757
• Report Number: 3000219639-2022-00015
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

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
• Device Operator: Health Professional
• Device Model Number: 7900-0
• Device Catalogue Number: 7900-0
• Device Lot Number: 220124B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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