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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MARUS MARUS DENTAL CHAIR
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MARUS MARUS DENTAL CHAIR Back to Search Results
Model Number DC1320
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/02/2015
Event Type  malfunction  
Event Description
A dental professional was performing routine medical treatment to a patient when the swivel weld assembly broke on a marus dental chair causing the upper structure of the chair to fall off the lower section of the chair.There were no injuries reported.
 
Manufacturer Narrative
Upon evaluation by the local marus distributor technician, it was identified that the swivel weld assembly broke apart at the weld.The part was not given to the distributor by the doctor therefore ther part was not returned to marus for evaluation.The dental chair is over 13 years old and is past the life of the device.
 
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Brand Name
MARUS DENTAL CHAIR
Type of Device
DENTAL CHAIR
Manufacturer (Section D)
MARUS
11727 fruehauf dr.
charlotte NC 28273
Manufacturer Contact
frank ray
11727 fruehauf dr.
charlotte, NC 28273
7045877227
MDR Report Key4745076
MDR Text Key5827469
Report Number1017522-2015-00006
Device Sequence Number1
Product Code EAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDC1320
Device Catalogue NumberDC1320
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/03/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2001
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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