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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLEXICARE MEDICAL (DONGGUAN) LTD. FLEXICARE ADULT BIPAP SINGLE LIMB HEATED HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
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FLEXICARE MEDICAL (DONGGUAN) LTD. FLEXICARE ADULT BIPAP SINGLE LIMB HEATED HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER Back to Search Results
Model Number 038-31-601U
Device Problems Overfill (2404); Appropriate Term/Code Not Available (3191)
Patient Problems Aspiration/Inhalation (1725); Hypoxia (1918); Low Oxygen Saturation (2477); Respiratory Failure (2484)
Event Date 12/28/2021
Event Type  Injury  
Event Description
It was reported through our event reporting system that the flexicare heater chamber overfilled and infiltrated the patient circuit of a patient on phillips v60. It is further reported that the patient potentially aspirated water contents that reached the mask and became dusky/hypoxic with o2 levels in the 50s even with supplemental oxygen via non-rebreather mask. A rapid response was called, and the patient was intubated due to respiratory failure. Patient was transferred from medical floor to icu based on this event. Fda safety report id# (b)(4).
 
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Brand NameFLEXICARE ADULT BIPAP SINGLE LIMB HEATED
Type of DeviceHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
Manufacturer (Section D)
FLEXICARE MEDICAL (DONGGUAN) LTD.
urvine CA 92618
MDR Report Key13151681
MDR Text Key283252239
Report NumberMW5106424
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number038-31-601U
Device Lot Number210302068
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/03/2022 Patient Sequence Number: 1
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