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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTARAUTO HT HUM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESPIRONICS, INC. REMSTARAUTO HT HUM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number DS560TBT
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Dry Eye(s) (1814); Headache (1880)
Event Date 02/01/2024
Event Type  malfunction  
Event Description
The manufacturer received information in relation to a remstar auto a-flex unit.The patient alleged that he has headache, and the eyes are dry and suspected that this incident is associated with the usage of the device.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
Manufacturer Narrative
H3 other text : device not returned to manufacturer.
 
Manufacturer Narrative
The manufacturer received information from hong kong in relation to a remstar auto a-flex unit.The patient alleged that he has headache, and the eyes are dry and suspected that this incident is associated with the usage of the device.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.In this report, these sections: describe event or problem (b5) and reporter country have been updated.
 
Event Description
The manufacturer received information from hong kong in relation to a remstar auto a-flex unit.The patient alleged that he has headache, and the eyes are dry and suspected that this incident is associated with the usage of the device.There was no allegation of serious or permanent harm or injury.No medical intervention was required for 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
REMSTARAUTO HT HUM
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 15208
4125423300
MDR Report Key18729777
MDR Text Key336052496
Report Number2518422-2024-08208
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K131982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDS560TBT
Device Catalogue NumberDS560TBT
Was Device Available for Evaluation? No
Date Manufacturer Received02/01/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/19/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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