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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. B & F HUMIDIFIER BUBBLER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
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ALLIED HEALTHCARE PRODUCTS, INC. B & F HUMIDIFIER BUBBLER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) Back to Search Results
Model Number 64376
Device Problems Leak/Splash (1354); Defective Device (2588); Improper Flow or Infusion (2954); Physical Resistance/Sticking (4012)
Patient Problem Low Oxygen Saturation (2477)
Event Date 07/05/2021
Event Type  Injury  
Event Description
B & f medical / allied healthcare products: oxygen humidifier failed.Product # 64376.This humidifier has a weighted 3 psi relief valve that constantly leaks and will even get stuck in the open position.Video evidence obtained.With a 3 lpm oxygen source, the user end cannula only puts out 1/2 lpm, the balance of the oxygen flows out the relief valve.We checked with several hospitals that use this humidifier and they have had complaints about the same issue but no one has ever reported the problem.There are numerous reports of patients desaturating when using the b and f humidifier.Most other brands use a spring loaded relief valve with no issues.Video of humidifier failing (b)(6).Fda safety report id # (b)(4).
 
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Brand Name
B & F HUMIDIFIER BUBBLER
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Manufacturer (Section D)
ALLIED HEALTHCARE PRODUCTS, INC.
MDR Report Key12173150
MDR Text Key261987974
Report NumberMW5102546
Device Sequence Number1
Product Code BTT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number64376
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention; Disability;
Patient Age84 YR
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