DEVILBIS 1.2 LITER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-22 for DEVILBIS 1.2 LITER * manufactured by Caire.

Event Text Entries

[191833] The resident was walking with their walker into the dining room at approximately 1645 hrs, to sit down at the dining room table prior to the evening meal, they stated in a loud manner, "my nose is burning, my nose is burning". The oxygen tubing was immediately removed from the resident's nose and face and the nurse turned off the flow of oxygen. Nurse then carried the container outside. The oxygen tubing was frozen and it appeared that liquid oxygen was coming out the nasal cannula when it was removed from the resident. The resident was examined immediately and warm moist packs were applied to the facial area. The physician and family were notified. The physician ordered k-y jelly to moisten the nares and to return a call to the physician for a referral to an ent physician, if condition worsened or blisters became apparent. The physician was telephoned and orders were received for an ent consult. The resident saw an ent physician on 1/25. The ent physician prescribed a nasal spray to be used multiple times daily. The resident's condition continued to improve and no further treatment was required. The administrator secured the portable oxygen unit in the office. They called and left a message on a cell phone voice mail at approximately 1715 hrs to the leasor. The president of the leasing co returned the call within 10 mins and discussed the situation with the administrator. It was determined that the device was to remain in the administrator's office until the following morning when it was picked-up by the leasing co, who then forwarded the oxygen unit to the mfr on 1/21/2000. The mfr is currently evaluating the functional status of the equipment. Facility is awaiting a response of their results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number267166
MDR Report Key267166
Date Received2000-02-22
Date of Report2000-02-18
Date of Event2000-01-20
Date Facility Aware2000-01-20
Report Date2000-02-18
Date Reported to FDA2000-02-18
Date Reported to Mfgr2000-02-18
Date Added to Maude2000-03-08
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDEVILBIS 1.2 LITER
Generic NamePORTABLE LIQUID OXYGEN
Product CodeBXJ
Date Received2000-02-22
Returned To Mfg2000-01-21
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age10 MO
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key258629
ManufacturerCAIRE
Manufacturer Address3505 COUNTY RD 42 W BURNSVILLE MN 55306 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2000-02-22

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