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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESPIRONICS, INC. DREAMSTATION AUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number FRX500S14
Device Problem Degraded (1153)
Patient Problem Pulmonary Embolism (1498)
Event Date 09/01/2021
Event Type  Injury  
Event Description
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleges to having had a bilateral pulmonary embolism-(b)(6) 2021 requiring resuscitation and intensive care.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 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 Key14251940
MDR Text Key290398869
Report Number2518422-2022-16051
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,Health Professional
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberFRX500S14
Device Catalogue NumberFRX500S14
Was Device Available for Evaluation? No
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2019
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; Other;
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