Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARIBEX, INC. NOMAD PRO; EXTRAORAL SOURCE X-RAY SYSTEM
  • 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
 

ARIBEX, INC. NOMAD PRO; EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number FF-0005
Device Problem Battery Problem (2885)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 09/08/2014
Event Type  malfunction  
Event Description
Customer reported that the battery pack (handset) of the unit started smoking on charging cradle.No injuries were reported.
 
Manufacturer Narrative
The handset was received and inspected.Our records indicate that the handset and the device were assembled (b)(6) 2012.Expected end of life for the battery is 300 charge/discharge cycles as per the user manual.The unit was inspected and it was determined that the failure was due to an over-discharge of the battery that led to a thermal event.The heat from the battery failure led to small burn marks on the inside bottom of the handset.The battery handset enclosure was not compromised.There were no injuries reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NOMAD PRO
Type of Device
EXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
ARIBEX, INC.
744 south 400 east
orem UT 84651
Manufacturer Contact
sanjay ahuja
744 south 400 east
orem, UT 84097
2679541463
MDR Report Key4240007
MDR Text Key4993009
Report Number3005417494-2014-00003
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081664
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 10/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberFF-0005
Device Catalogue NumberFF-0005
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/02/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/02/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-