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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARESTREAM HEALTH, INC. 8900 DRYVIEW LASER; 8900 DRYVIEW LASER IMAGER
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CARESTREAM HEALTH, INC. 8900 DRYVIEW LASER; 8900 DRYVIEW LASER IMAGER Back to Search Results
Model Number 8900
Device Problem Electronic Property Issue (2928)
Patient Problem No Patient Involvement (2645)
Event Date 09/12/2014
Event Type  malfunction  
Event Description
Customer reported a burning odor coming from the unit.
 
Manufacturer Narrative
The device was returned to carestream.A root cause investigation is currently in progress.A follow up report will be submitted.A follow up report will be submitted.The site at which the unit was manufactured is now closed and this product is no longer manufactured.
 
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Brand Name
8900 DRYVIEW LASER
Type of Device
8900 DRYVIEW LASER IMAGER
Manufacturer (Section D)
CARESTREAM HEALTH, INC.
rochester NY
Manufacturer (Section G)
OAKDALE (COLUMBIA PLANT)
1 imation way
oakdale MN 55128
Manufacturer Contact
150 verona st
rochester, NY 14608
5856278230
MDR Report Key4156087
MDR Text Key4916814
Report Number2134259-2014-00016
Device Sequence Number1
Product Code LMC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090469
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/07/2014
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
Device Operator Health Professional
Device Model Number8900
Device Catalogue Number1780774
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/14/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/12/2014
Initial Date FDA Received09/29/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2006
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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