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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. CYLINDER, ULTRAFILL; GENERATOR, OXYGEN, PORTABLE
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RESPIRONICS, INC. CYLINDER, ULTRAFILL; GENERATOR, OXYGEN, PORTABLE Back to Search Results
Device Problem Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 12/18/2018
Event Type  malfunction  
Event Description
The manufacturer received information alleging a cylinder became disconnected from the ultrafill device.There was no report of patient harm or injury.The investigation is still ongoing.A follow up report will be submitted when the manufacturer has completed the investigation.
 
Manufacturer Narrative
The manufacturer previously reported a cylinder that allegedly became disconnected from the ultrafil device.There was no report of patient harm or injury.The manufacturer contacted the reporting facility and was informed the device is not returning to the manufacturer for evaluation.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
 
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Brand Name
CYLINDER, ULTRAFILL
Type of Device
GENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
RESPIRONICS, INC.
175 chastian meadows court
kennesaw GA 30144 3724
MDR Report Key8231413
MDR Text Key132523364
Report Number1040777-2019-00002
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
PMA/PMN Number
K091191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received01/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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