MAUDE Adverse Event Report: SALTER LABS SALTER LABS HUMIDIFIER

Model Number 7900

Device Problem Partial Blockage (1065)

Patient Problem Hypoxia (1918)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

Initial and final report.Caregiver reports patient saturation from 98% to 57% due to occlusion in humidifier.Caregiver was questioned regarding device and reports that after reviewing the device, the occlusion is most likely due to adding saline in water leading to precipitation which blocked some of the openings in the tubing.Labeling states "use sterile, distilled or tap water".Labeling states to clean every 3 days and to discard/replace humidifier if scaling or deposits hoted.Humidifer was in use for at least 5 days prior to event.User not following cleaning and usage instructions.No serious/long-term injury reported.No other similar events reported.Event root cause determined to be user error.

Event Description

Caregiver reports patient saturation from 98% to 57% due to occlusion in humidifier - user error.

• Brand Name: SALTER LABS HUMIDIFIER
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SALTER LABS; 2365 camino vida roble; carlsbad, ca
• Manufacturer (Section G): SALTER LABS; 2365 camino vida roble; carlsbad, ca
• Manufacturer Contact: mara caler ; 2365 camino vida roble; carlsbad, ca ; 7957100
• MDR Report Key: 9759581
• MDR Text Key: 191198310
• Report Number: 3000219639-2020-00003
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7900
• Device Catalogue Number: 7900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other