UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for UNKNOWN manufactured by Ohmeda Medical.

Event Text Entries

[140149538] Oxygen wall port leaking. Maintenance turned off o2 and was unable to fix. Pt was requiring oxygen so was moved to another room. Mother was unhappy regarding the move but was understanding. Room out of service until repair takes place. Note: no identifiers are available from the wall plate itself. Maintenance had the unit repaired in 24 hrs. Many of the wall ports are "wiggly", mainly due to age of the unit and the installation process unable to locate sn, model #, or other identifier.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8458950
MDR Report Key8458950
Date Received2019-03-28
Date of Report2019-03-11
Date of Event2019-01-29
Report Date2019-03-11
Date Reported to FDA2019-03-11
Date Reported to Mfgr2019-03-28
Date Added to Maude2019-03-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameUNKNOWN
Generic NameREGULATOR, PRESSURE, GAS CYLINDER
Product CodeCAN
Date Received2019-03-28
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerOHMEDA MEDICAL
Manufacturer Address3030 OHMEDA DRIVE MADISON WI 53718 US 53718

Device Sequence Number: 1

Brand NameUNKNOWN
Generic NameREGULATOR, PRESSURE, GAS CYLINDER
Product CodeCAN
Date Received2019-03-28
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOHMEDA MEDICAL
Manufacturer Address3030 OHMEDA DRIVE MADISON WI 53718 US 53718


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-28

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