MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK ULTRATRIM DENTAL CHAIR

Model Number	153758-003
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a consolidation of reports summarized as part of the fda voluntary malfunction summary reporting program.Three events were reported in quarter 4 of 2019.The three events did not have patient involvement and had no reported injuries.The three devices will not be returned for evaluation and were serviced in the field.Due to the three dental chairs not being returned, an equivalent device on site is being used to perform the evaluation to try to recreate the issue to determine the root cause.
Event or Problem Description
This report summarizes 3 malfunction events.One event stated that the dental chair back was not working as intended and upon further inspection it was found that both back casting bolts were backed out.The two other events stated that the bolts to the back casting were inspected and all four bolts were found to be loose and were backing out.The three events reported no injury or patient involvement.

• Brand Name: MIDMARK ULTRATRIM DENTAL CHAIR
• Common Device Name: DENTAL CHAIR
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• MDR Report Key: 9603805
• Report Number: 1523530-2019-00005
• Device Sequence Number: 458777
• Product Code: NRU
• UDI-Device Identifier: 00841709108976
• UDI-Public: 00841709108976
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 153758-003
• Device Catalogue Number: 153758-003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1