CUFFLATOR ENDO TUBE INFLATOR & MANOMETER 8199

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-30 for CUFFLATOR ENDO TUBE INFLATOR & MANOMETER 8199 manufactured by J. T. Posey Co..

Event Text Entries

[3110902] The customer reported the cufflator does not hold pressure during set-up. The customer did not provide the date when this was discovered. There was no patient incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5


[10350470] Results? Eval of the returned product confirmed the reported issue. When pressure is attempted on the cufflator the needle moves up but comes down slowly on its own. The needle sits -2cm below zero on the dial. No physical damages to the unit found. Note: the instructions for use state: the cufflator should be calibrated annually, or if measurements all outside of a specific range, or if the cufflator needle does not indicate a reading of zero when nothing is connected, or if the unit is ever dropped. Never open the cufflator body. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2020362-2012-00662
MDR Report Key2903084
Report Source05,06
Date Received2012-11-30
Date of Report2012-11-12
Date Mfgr Received2012-11-12
Date Added to Maude2013-03-07
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 FDA0
Event Location0
Manufacturer ContactPAM WAMPLER
Manufacturer Street5635 PECK RD.
Manufacturer CityARCADIA CA 91006
Manufacturer CountryUS
Manufacturer Postal91006
Manufacturer Phone6264433143
Manufacturer G1J. T. POSEY CO.
Manufacturer Street5635 PECK RD.
Manufacturer CityARCADIA CA 91006
Manufacturer CountryUS
Manufacturer Postal Code91006
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCUFFLATOR ENDO TUBE INFLATOR & MANOMETER
Product CodeBSK
Date Received2012-11-30
Returned To Mfg2012-11-19
Model Number8199
Catalog Number8199
Lot Number02152319
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerJ. T. POSEY CO.
Manufacturer Address5635 PECK RD. ARCADIA CA 91006 US 91006


Patients

Patient NumberTreatmentOutcomeDate
10 2012-11-30

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