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: MEDIANA CO. LTD. NELLCOR; OXIMETER
  • 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
 

MEDIANA CO. LTD. NELLCOR; OXIMETER Back to Search Results
Model Number DOC10
Medical Device Problem Code Incorrect Measurement (1383)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/14/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during use, the device had false/unreliable reading of the spo2 and the pleth.They replaced the sensor with a new cable, but the issue was remaining inadequate reading.It was never clear when exactly the false value did appear.It was on several different children with different conditions.There was no patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NELLCOR
Common Device Name
OXIMETER
Manufacturer (Section D)
MEDIANA CO. LTD.
1650 1 2 donghwa ri munmak eu
kangwon do wonju si 220-8 01
KR  220-801
MDR Report Key9814038
Report Number2936999-2020-00200
Device Sequence Number11513705
Product Code DQA
UDI-Device Identifier10884522042468
UDI-Public10884522042468
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K012891
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/10/2020
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
Operator of Device Health Professional
Device Model NumberDOC10
Device Catalogue NumberDOC10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/24/2020
Initial Report FDA Received Date03/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-