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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OXYGEN MASK; MASK, OXYGEN, NON-REBREATHING

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UNOMEDICAL S.A. DE C.V. OXYGEN MASK; MASK, OXYGEN, NON-REBREATHING Back to Search Results
Model Number H-3104
Device Problem Disconnection (1171)
Patient Problem Hypoxia (1918)
Event Date 10/12/2014
Event Type  Injury  
Event Description
A health care professional reported the oxygen tubing detached from the oxygen mask during use.The patient was being treated for decreased oxygenation levels (oxygen saturation level was reportedly measured as 84%) at the time of the event.Based on additional information provided, acceptable saturation for patients should be greater than 90%.Oxygen mask was replaced.An optiflow device was used to receive additional oxygenation therapy.
 
Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.
 
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Brand Name
OXYGEN MASK
Type of Device
MASK, OXYGEN, NON-REBREATHING
Manufacturer (Section D)
UNOMEDICAL S.A. DE C.V.
av. industrial falcon secc. 4
lote 7, parque ind. del norte
reynosa, tams. 8873 6
MX  88736
Manufacturer Contact
matthew walenciak, associate dir.
211 american ave
greensboro, NC 27409
9083779293
MDR Report Key4250030
MDR Text Key17693440
Report Number9680866-2014-00039
Device Sequence Number1
Product Code KGB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 10/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2019
Device Model NumberH-3104
Device Lot Number104901
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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