8066-910

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2009-08-08 for 8066-910 manufactured by Western / Scott Fetzer Company.

Event Text Entries

[18916042] During installation of portable equipment in a dental clinic, it was discovered by a medical gas verifier that the yoke index pins can be pushed out of the yoke body if the wrong gas cylinder is installed. This may compromise the pin index safety system of the yoke connection by permitting the connection of a gas cylinder post valve of one gas type to a yoke connection of another gas type. The problem was spotted before the unit was used for treatment. Western has not received any reports of such an improper connection nor any reports of a patient being exposed to an incorrectly-connected medical gas system. Thus, there have been no patient injuries associated with the affected product.
Patient Sequence No: 1, Text Type: D, B5


[19117195] One nitrous oxide yoke assembly was returned. The right index pin was pushed inward approx. . 093 inches and was protruding from the back of the yoke body. The yoke pin holes extend through the back of the yoke body in these models. Testing of samples found the yoke pins can be pushed inward back through the yoke body with torques applied to the yoke screw in the range of 6-15 ft-lbs. This torque is 2 - 2 1/2 times greater than the torque that can be generated with the yoke screw supplied with the assembly. Investigation revealed various customer use practices that may contribute to the application of torques that may exceed those intended or typically needed to achieve a seal and which may exceed the force required to displace the pins. Mismatching gas types between post valve and yoke an/or misalignment between the two, use of different style yoke screws other than the style supplied and/or use of tools to tighten the yoke screw connection, use of different yoke seal washers other than the style supplied with the assembly, which may require increasingly higher torque to achieve a gas tight seal. Although the occurrence was considered remote, western is performing a recall of affected product. Western has designed a back-up plate to be installed between the medical gas yoke assembly and the manifold block to which it is attached. Once installed, the back-up plate serves as a positive stop for the yoke pins preventing them from being displaced and thereby maintaining the integrity of the yoke pin index safety system. Western has not received any reports of such an improper connection nor any reports of a patient being exposed to an incorrectly-connected medical gas system. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1526809-2009-00001
MDR Report Key1473070
Report Source05,08
Date Received2009-08-08
Date of Report2009-08-07
Date Mfgr Received2008-11-21
Date Added to Maude2010-08-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDAVID SIMO, DIRECTOR
Manufacturer Street875 BASSETT ROAD
Manufacturer CityWESTLAKE OH 44145
Manufacturer CountryUS
Manufacturer Postal44145
Manufacturer Phone8007837890
Manufacturer G1.
Single Use3
Remedial ActionMA
Previous Use Code3
Removal Correction Number1526809-8/7/09-001-C
Event Type3
Type of Report3

Device Details

Generic NameMEDICAL GAS YOKE ASSEMBLY
Product CodeCAM
Date Received2009-08-08
Returned To Mfg2008-12-10
Model Number8066-910
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerWESTERN / SCOTT FETZER COMPANY
Manufacturer AddressWESTLAKE OH 44145 US 44145


Patients

Patient NumberTreatmentOutcomeDate
10 2009-08-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.