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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA O2 STAR OXYGEN MASK; MASKS, AIR-OXYGEN
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DRÄGERWERK AG & CO. KGAA O2 STAR OXYGEN MASK; MASKS, AIR-OXYGEN Back to Search Results
Catalog Number MP01920
Device Problems Decrease in Pressure (1490); Inaccurate Delivery (2339); Detachment of Device or Device Component (2907); Gas/Air Leak (2946)
Patient Problem Insufficient Information (4580)
Event Date 10/06/2023
Event Type  Death  
Event Description
It was reported that the tube connected to the oxygen mask came off while using on a palliative care ward.A nurse confirmed that a patient had died.The causal relationship with the tube coming off the mask is unknown.
 
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
 
Manufacturer Narrative
One packaged and one unpackaged mask was sent by the customer.They showed no deviation.Additionally 20 masks from stock were inspected which showed no deviation as well.The root cause for the reported event is unknown.According to the ifu appropriate monitoring (e.G.Spo2) need to be ensured for the therapeutic effect.In this case no spo2 monitoring was used.Also a safe connection to the o2 mask need to be ensured.The causal correlation with the tube coming off the mask and the patient's death is unknown.
 
Event Description
It was reported that the tube connected to the oxygen mask came off while using on a palliative care ward.A nurse confirmed that a patient had died.The causal relationship with the tube coming off the mask is unknown.
 
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Brand Name
O2 STAR OXYGEN MASK
Type of Device
MASKS, AIR-OXYGEN
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM 
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
Manufacturer Contact
moislinger allee 53-55
lübeck 23542
4518822868
MDR Report Key17974366
MDR Text Key326137103
Report Number9611500-2023-00373
Device Sequence Number1
Product Code KGB
Combination Product (y/n)N
PMA/PMN Number
DLN D210733
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMP01920
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/23/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
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