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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. CYLINDER,ULTRAFILL,MB08,3000 PSI; GENERATOR, OXYGEN, PORTABLE
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RESPIRONICS, INC. CYLINDER,ULTRAFILL,MB08,3000 PSI; GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1065715
Device Problem Device Operational Issue (2914)
Patient Problem No Patient Involvement (2645)
Event Date 04/03/2018
Event Type  malfunction  
Manufacturer Narrative
Evaluation conclusion: the device was replaced.
 
Event Description
The manufacturer received information alleging an oxygen cylinder became disconnected from the ultrafill device.There was no report of patient harm or injury.The ultrafill device and cylinder were returned to the manufacturer for evaluation.The manufacturer confirmed the burst disk ruptured in the cylinder causing the cylinder to separate from the ultrafill unit.
 
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Brand Name
CYLINDER,ULTRAFILL,MB08,3000 PSI
Type of Device
GENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
RESPIRONICS, INC.
175 chastian meadows court
kennesaw GA 30144 3724
Manufacturer (Section G)
RESPIRONICS, INC.
175 chastian meadows court
kennesaw GA 30144 3724
Manufacturer Contact
adam price
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key7465352
MDR Text Key106661160
Report Number1040777-2018-00017
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 04/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1065715
Device Catalogue Number1065715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/03/2018
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
ULTRAFILL DEVICE, (B)(4).
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