FDA.reportPublic FDA data

MAUDE MDR 50155

MDR report key
50155
Report number
2518157-1996-00002
Event key
0
Event type
3
Date received
1996-11-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MXR-2000ANALGESIA GAS MACHINEPORTER INTSTRUMENT COMPANY, INC.LWMMXR-2000MXR-2000NANYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11996-11-1501. O

Event Narratives#

D

Patient 1

A FIELD COMMUNICATION REPORT WAS RECEIVED FROM A DEALER WHO WAS PERFORMING AN INITIAL INSTALLATION OF A CO'S ANALGESIA GAS MACNINE WHICH SAID THAT "HE HAD SEEN 100% N2O FLOW." THIS INSTRUMENT IS DESIGNED TO DELIVER MIXED O2 AND N2O TO A DENTAL PT. WHEN O2 FLOW OR PRESSURE IS NOT PRESENT, THE INSTRUMENT HAS A FEATURE WHICH STOPS THE FLOW OF N2O. THIS FEATURE, THEREFORE, HAD MALFUNCTIONED. THE REPORTING SOURCE INDICATED THAT THIS WAS A NEW INSTALLATION WHEN HE WAS PERFORMEING THE SAFETY CHECKS AND NO PT WAS CONNECTED TO THE SYSTEM. THE UNIT WAS RETURNED FOR REPAIR AND WAS RECEIVED ON 8/19/96. CO HAD PREVIOUSLY SUBMITTED MDRS WHEN THE FAILSAFE HAS MALFUNCTIONED, EVEN WHEN ONLY IN A CO TEST AS IN THE CASE OF THI UNDER CURRENT MDR REGULATIONS, CO HAS DETERMINED THAT THIS CATEGORY OF PRODUCT MALFUNCTION DOES NOT REQUIRE SUBMISSION OF AN MDR AND HAS FILED AN EXEMPTION WITH THE FDA ON 11/6/96.