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 NELLCOR; PULSE 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 NELLCOR; PULSE OXIMETER Back to Search Results
Model Number PM100N
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem Low Oxygen Saturation (2477)
Event Date 06/02/2015
Event Type  malfunction  
Event Description
It was reported that when the monitor alarm had reached the lower alarm limit, and as the patient's saturation decreased, the monitor reported readings up to a certain point and then posted a 0 and would not show any further readings as the saturation decreased.The customer stated it was difficult to assess the condition of the patient to determine whether to take necessary action.There is no report of serious injury or death associated with this event.
 
Manufacturer Narrative
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NELLCOR
Type of Device
PULSE OXIMETER
Manufacturer (Section D)
MEDIANA
wonju industry park; dongwha-r
gangwon-do
TH 
Manufacturer (Section G)
MEDIANA
wonju industry park; dongwha-ri,munmak-eup, wonju-s
gangwon-do
TH  
Manufacturer Contact
thom mcnamara
15 hampshire street
mansfield, MA 02048
5084524811
MDR Report Key4862213
MDR Text Key17204184
Report Number2936999-2015-00551
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K822909
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPM100N
Device Catalogue NumberPM100N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-