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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP ST30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

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RESPIRONICS, INC. DREAMSTATION BIPAP ST30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING Back to Search Results
Model Number DSX1030T11C
Device Problems Degraded (1153); Device Emits Odor (1425)
Patient Problems Chest Pain (1776); Nausea (1970); Dysgeusia (4424); Unspecified Gastrointestinal Problem (4491)
Event Date 06/21/2021
Event Type  malfunction  
Manufacturer Narrative
H3 other text : device not returned to manufacturer.
 
Event Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging "device has strange odor." the patient alleges "nausea, and the machine makes her stomach hurt and she gets the dry heaves in the morning.It makes her mouth taste bad.She sometimes get a pain at the top of her chest.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
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Brand Name
DREAMSTATION BIPAP ST30
Type of Device
VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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 15208
4125423300
MDR Report Key17431248
MDR Text Key320158781
Report Number2518422-2023-17687
Device Sequence Number1
Product Code MNS
UDI-Device Identifier00606959045606
UDI-Public00606959045606
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDSX1030T11C
Device Catalogue NumberDSX1030T11C
Was Device Available for Evaluation? No
Date Manufacturer Received06/21/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/21/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberRES 88058
Patient Sequence Number1
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