PORTEX CUFF INFLATOR PRESSURE GAUGE WITH CONNECTING TUBES 100/568/000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-01-11 for PORTEX CUFF INFLATOR PRESSURE GAUGE WITH CONNECTING TUBES 100/568/000 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[132863936] Information was received that a smiths medical cuff inflator does not release air. The arrow on the gauge does not return to 0. Another was used and no patient injury resulted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2019-00159
MDR Report Key8241493
Report SourceFOREIGN,USER FACILITY
Date Received2019-01-11
Date of Report2019-03-22
Date of Event2018-12-06
Date Mfgr Received2018-12-12
Date Added to Maude2019-01-11
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 ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone7633833310
Manufacturer G1SMITHS MEDICAL, ASD INC.
Manufacturer StreetBOUNDARY ROAD
Manufacturer CityKENT, HYTHE
Manufacturer CountryUK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX CUFF INFLATOR PRESSURE GAUGE WITH CONNECTING TUBES
Generic NameMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)
Product CodeCAP
Date Received2019-01-11
Returned To Mfg2019-01-10
Catalog Number100/568/000
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-11

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