KING MASK * 1065

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-17 for KING MASK * 1065 manufactured by King Systems Corporation.

Event Text Entries

[16749343] Anesthesiologist reported a defect in the seal between the inflatable rim of the mask and the plastic base resulting in an inadequate seal for ventilation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2663498
MDR Report Key2663498
Date Received2012-07-17
Date of Report2012-07-17
Date of Event2012-07-06
Report Date2012-07-17
Date Reported to FDA2012-07-17
Date Added to Maude2012-07-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameKING MASK
Generic NameMASK, GAS, ANESTHETIC
Product CodeBSJ
Date Received2012-07-17
Model Number*
Catalog Number1065
Lot NumberIZTV1
ID Number*
OperatorPHYSICIAN
Device AvailabilityN
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerKING SYSTEMS CORPORATION
Manufacturer Address15011 HERRIMAN BLVD. NOBLESVILLE IN 46060 US 46060


Patients

Patient NumberTreatmentOutcomeDate
10 2012-07-17

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