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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. CYLINDER,ULTRAFILL,ME36,3000 PSI; GENERATOR, OXYGEN, PORTABLE
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RESPIRONICS, INC. CYLINDER,ULTRAFILL,ME36,3000 PSI; GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1065718
Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 01/05/2018
Event Type  malfunction  
Event Description
The manufacturer received information alleging a oxygen cylinder became disconnected from the ultrafil device.There was no report of patient harm or injury.The investigation is still ongoing.A follow up report will be filed when the manufacturer has completed the investigation.
 
Manufacturer Narrative
The manufacturer previously reported an oxygen cylinder allegedly became disconnected from the ultrafill device.There was no report of patient harm or injury.The device was returned to the manufacturer for evaluation.The customer's complaint was not duplicated.
 
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Brand Name
CYLINDER,ULTRAFILL,ME36,3000 PSI
Type of Device
GENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
RESPIRONICS, INC.
175 chastian meadows court
kennesaw GA 30144 3724
MDR Report Key7215287
MDR Text Key98301099
Report Number1040777-2018-00002
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 01/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1065718
Device Catalogue Number1065718
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2018
Was the Report Sent to FDA? No
Date Manufacturer Received12/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ULTRAFILL, SN (B)(4)
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