CYLINDER,ULTRAFILL,MD22,3000 PSI 1065721

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-12 for CYLINDER,ULTRAFILL,MD22,3000 PSI 1065721 manufactured by Philips Respironics Inc..

Event Text Entries

[178786210] The manufacturer received information alleging a cylinder became disconnected from the ultrafill device. There was no report of patient harm or injury. The device has yet to be returned to the manufacturer for evaluation. A follow up report will be filed when the manufacturer has completed the investigation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2518422-2020-00337
MDR Report Key9699553
Report SourceUSER FACILITY
Date Received2020-02-12
Date of Report2020-01-31
Date of Event2020-01-31
Date Mfgr Received2020-01-31
Date Added to Maude2020-02-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactADAM PRICE
Manufacturer Street1001 MURRY RIDGE LANE
Manufacturer CityMURRYSVILLE PA 15668
Manufacturer CountryUS
Manufacturer Postal15668
Manufacturer G1PHILIPS RESPIRONICS INC.
Manufacturer Street1001 MURRY RIDGE LANE
Manufacturer CityMURRYSVILLE PA 15668
Manufacturer CountryUS
Manufacturer Postal Code15668
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCYLINDER,ULTRAFILL,MD22,3000 PSI
Generic NameGENERATOR, OXYGEN, PORTABLE
Product CodeCAW
Date Received2020-02-12
Model Number1065721
Catalog Number1065721
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS RESPIRONICS INC.
Manufacturer Address1001 MURRY RIDGE LANE MURRYSVILLE PA 15668 US 15668


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-12

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