• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARESTREAM DENTAL CS 2200

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARESTREAM DENTAL CS 2200 Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCS 2200
Type of DeviceCS 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 Key12924567
MDR Text Key286084109
Report Number3002522649-2021-00002
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060292
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received12/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCS 2200
Device Catalogue Number5153598
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-