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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESPIRONICS, INC. DREAMSTATION BIPAP AUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number FRX700S14
Device Problem Degraded (1153)
Patient Problems Anemia (1706); Fatigue (1849); Hemorrhage/Bleeding (1888); Pain (1994)
Event Date 03/09/2022
Event Type  Injury  
Event Description
The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused anemia, bleeding on the lips, oral mucosa, fatigue and bone pain.The patient did receive medical intervention and was hospitalized and saw several specialists.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
 
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Brand Name
DREAMSTATION BIPAP AUTO
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
kimberly shelly
6501 living place
pittsburgh, PA 15206
2673970028
MDR Report Key13804215
MDR Text Key287400853
Report Number2518422-2022-10757
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K131982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date 03/17/2022
1 Device was Involved in the Event
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 NumberFRX700S14
Device Catalogue NumberFRX700S14
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/09/2022
Initial Date FDA Received03/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberRES 88058
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Other;
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