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: COVIDIEN NELLCOR N600X 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
 

COVIDIEN NELLCOR N600X OXIMETER Back to Search Results
Model Number N600X
Device Problems Failure to Reset (1532); Improper or Incorrect Procedure or Method (2017); No Fail-Safe Mechanism (2990)
Patient Problems Death (1802); Muscle Weakness (1967); Low Oxygen Saturation (2477)
Event Date 07/03/2014
Event Type  Death  
Event Description
(b)(6), case manager at (b)(6) home care nursing, called to report that pt passed away unexpectedly.(b)(6) reported that the day nurse same in to the pt's room when starting her shift (a little after 7:00 am).She found that the oximeter was not on.When she turned the oximeter, she reported that she thought that it was strange because "it did not beep".Pt was on the trilogy, being ventilated noninvasively (using a nasal bilevel mask).Pt was not responsive, so nurse initiated cpr immediately, but pt passed away.Pts were in bed prior to the event.The cause of death is uncertain.It does not appear that there were any alarms on the trilogy prior to cpr being initiated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NELLCOR N600X OXIMETER
Type of Device
N600X
Manufacturer (Section D)
COVIDIEN
15 hampshire st.
mansfield MA 02048
MDR Report Key4146725
MDR Text Key4769425
Report Number4146725
Device Sequence Number1
Product Code DQA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/17/2014,07/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberN600X
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/17/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/18/2014
Distributor Facility Aware Date07/03/2014
Device Age66 MO
Event Location Home
Date Report to Manufacturer07/18/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
(ORDERED BY PHYSICIAN); PT ALSO USED TRILOGY VENTILATOR TO MASK- ONLY; ALARM SET WAS THE DISCONNECT
Patient Outcome(s) Death;
Patient Age27 MO
-
-