MAUDE Adverse Event Report: SALTER LABS BUBBLE HUMIDIFIER 7600-0; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number 7600-0

Device Problems Leak/Splash (1354); No Flow (2991); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2020

Event Type  Injury  

Event Description

Blood o2 below 50%.Oxygen suddenly stopped flowing from output of salter labs bubble humidifier 7600-0 with no indication of failure.3 out of 3 failed after just a few hours use.Test showed leak at pressure relief valve.Tested relief valve per instructions and it activated and reset, but still leaked.First failure was noticed when patients lips turned blue.Replaced with 2nd unit and flow resumed until it suddenly stopped with no indication.Likewise with 3rd unit.Lot number (10) 062419.This is a serious problem that could cause death.See product recall from 2012 for same problem.Recall number: z-0803-2012 recall event id 60270.Fda safety report id #: (b)(4).

• Brand Name: BUBBLE HUMIDIFIER 7600-0
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): SALTER LABS
• MDR Report Key: 10361791
• MDR Text Key: 201855343
• Report Number: MW5095870
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 00607411700040
• UDI-Public: (01)00607411700040
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/02/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7600-0
• Device Catalogue Number: (01) 0 060741170004 0
• Device Lot Number: (10) 062419
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 54