MAXSTAR DC1690 DENTAL CHAIR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-03-03 for MAXSTAR DC1690 DENTAL CHAIR manufactured by Dental Equipment Llc (dba Newberg Manufacturing).

Event Text Entries

[1877570] A distributor had installed in their show room, for display purposes only, a dental chair with a rear mounted cuspidor mounted to it. The link arm assembly that holds the rear mounted cuspidor broke causing the cuspidor assembly to fall off the chair to the floor.
Patient Sequence No: 1, Text Type: D, B5


[9110840] Newberg manufacturing recently became aware of failures of the link arm assembly that connects some rear mounted options (cuspidors, assistants instrumentation, and hygiene systems) to the dental chair which may potentially break and fall off the dental chair. Outside lab testing determined that the failure was due to hydrogen embrittlement of the link arm bolt. This failure is caused by not properly baking the bolts after they are zinc plated in a timely manner. All bolt failures were from the same lot number. A decision was made by dental equipment llc to conduct a voluntary recall of the affected link arm assemblies. This complaint was reported to newberg manufacturing on (b)(4) 2011. This event happened at a distributor show room and based on the information provided at the time, we determined that it was not a reportable event. During our recall investigation, we revisited this case and determined that the bolt on this unit had the same malfunction as the complaints that led to the recall investigation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004517290-2011-00002
MDR Report Key2054065
Report Source08
Date Received2011-03-03
Date of Report2011-01-26
Date of Event2010-11-24
Date Mfgr Received2011-01-26
Device Manufacturer Date2010-11-01
Date Added to Maude2011-07-11
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 ContactFRANK RAY, MGR.
Manufacturer Street11727 FRUEHAUF DRIVE
Manufacturer CityCHARLOTTE NC 28273
Manufacturer CountryUS
Manufacturer Postal28273
Manufacturer Phone7045877227
Manufacturer G1DENTAL EQUIPMENT LLC, DBA NEWBERG MFG
Manufacturer Street705 S. SPRINGBROOK RD. BUILDING C
Manufacturer CityNEWBERG OR 97132
Manufacturer CountryUS
Manufacturer Postal Code97132
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAXSTAR DC1690 DENTAL CHAIR
Generic NameDENTAL CHAIR
Product CodeKLC
Date Received2011-03-03
Model NumberDC1690
Catalog NumberDC1690
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDENTAL EQUIPMENT LLC (DBA NEWBERG MANUFACTURING)
Manufacturer Address705 S. SPRINGBROOK RD. BUILDING C NEWBERG OR 97132 US 97132


Patients

Patient NumberTreatmentOutcomeDate
10 2011-03-03

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