MAUDE Adverse Event Report: CARESTREAM DENTAL CS 2200

Model Number	CS 2200
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Carestream dental has reviewed past complaints and noted that this is the only occurrence of this type of problem with the cs 2200.
Event or Problem Description
A cs 2200 unit arm fell while in use and bumped a patient.The patient was not seriously injured and did not require any medical attention.The unit was manufactured in 2016 and installed in march 2016.The unit was installed using a passthrough installation.From the photographic evidence it appears the housing may have been filed down during installation.No maintenance was performed on the unit as recommended in the installation and service guide (sm762)_ed06) over the life of the unit.
Additional Manufacturer Narrative
Carestream dental has reviewed past complaints and noted that this is the only occurrence of this type of problem with the cs 2200.
Event or Problem Description
A cs 2200 unit arm fell while in use and bumped a patient.The patient was not seriously injured and did not require any medical attention.The unit was manufactured in 2016 and installed in march 2016.The unit was installed using a passthrough installation.From the photographic evidence it appears the housing may have been filed down during installation.No maintenance was performed on the unit as recommended in the installation and service guide (sm762)_ed06) over the life of the unit.

• Brand Name: CS 2200
• Common Device Name: CS 2200
• Manufacturer (Section D): CARESTREAM DENTAL; 3625 cumberland boulevard; suite 700; atlanta GA 30339
• Manufacturer (Section G): CARESTREAM DENTAL; 3625 cumberland boulevard; suite 700; atlanta GA 30339
• Manufacturer Contact: raven wildharber ; 3625 cumberland boulevard; suite 700; atlanta, GA 30339 ; 4704818687
• MDR Report Key: 12924567
• Report Number: 3002522649-2021-00002
• Device Sequence Number: 5568807
• Product Code: EHD
• UDI-Device Identifier: 60192155153594
• UDI-Public: 60192155153594
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K060292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

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: CS 2200
• Device Catalogue Number: 5153598
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown