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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 Problems Disconnection (1171); Loose or Intermittent Connection (1371)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 12/28/2017
Event Type  malfunction  
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 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,MB08,3000 PSI
Type of Device
GENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
RESPIRONICS, INC.
175 chastian meadows court
kennesaw GA 30144 3724
MDR Report Key7270684
MDR Text Key100135845
Report Number1040777-2018-00004
Device Sequence Number1
Product Code CAW
UDI-Device Identifier00606959032477
UDI-Public00606959032477
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 01/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2018
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 Manufacturer04/05/2018
Was the Report Sent to FDA? No
Date Manufacturer Received01/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ULTRAFILL DEVICE, SERIAL NUMBER (B)(4)
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