MAUDE Adverse Event Report: CARESTREAM DENTAL CS 2200

Model Number CS 2200

Device Problem Unintended Application Program Shut Down (4032)

Patient Problem Swelling/ Edema (4577)

Event Date 11/05/2021

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 286084109
• Report Number: 3002522649-2021-00002
• Device Sequence Number: 1
• Product Code: EHD
• UDI-Device Identifier: 60192155153594
• UDI-Public: 60192155153594
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS 2200
• Device Catalogue Number: 5153598
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1