CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER 8199

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-02-20 for CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER 8199 manufactured by J. T. Posey Co..

Event Text Entries

[19200008] The customer reported the cufflator has an unstable pointer that will not go to zero on the dial. The customer did not provide the date when this was discovered. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


[19475863] Results: evaluation of the returned product confirmed the reported issue the needle does not return to zero when inflated, it will only return to 60 mmhg. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2020362-2013-00087
MDR Report Key3012593
Report Source06
Date Received2013-02-20
Date of Report2013-02-01
Date Mfgr Received2013-02-01
Date Added to Maude2013-05-01
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, ADMINISTRATOR
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 ENDOTRACHEAL TUBE INFLATOR AND MANOMETER
Product CodeBSK
Date Received2013-02-20
Returned To Mfg2013-02-07
Model Number8199
Catalog Number8199
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerJ. T. POSEY CO.
Manufacturer AddressARCADIA CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2013-02-20

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