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

MAUDE Adverse Event Report: ORIDION MEDICAL ORIDION ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

  • 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
 

ORIDION MEDICAL ORIDION ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number N85
Device Problems Device Damaged Prior to Use (2284); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
According to the reporter, prior to use, the unit had a crack case near to power switch and psu cable low voltage side locking tab was broken. There was no patient involvement.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameORIDION
Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
ORIDION MEDICAL
7 hamarpeh st.
jerusalem 91235
IS 91235
Manufacturer (Section G)
ORIDION MEDICAL
7 hamarpeh st.
jerusalem 91235
IS 91235
Manufacturer Contact
clay chandler
5920 longbow drive
boulder, CO 80301
3035306409
MDR Report Key13260611
MDR Text Key286940525
Report Number8044004-2022-00002
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN85
Device Catalogue NumberN85
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/06/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-