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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIANA CO. LTD. NELLCOR; OXIMETER
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MEDIANA CO. LTD. NELLCOR; OXIMETER Back to Search Results
Model Number 10005941J
Device Problems Image Display Error/Artifact (1304); High Readings (2459)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during use, the had an error code 901.The pulse rate was displayed double in value, alarm sounded and continued for about an hour.There was no patient harm.
 
Manufacturer Narrative
Additional information: d10, g4, h3, h5, h6, h8 h3.Evaluation summary: one device was received for evaluation and the reported event was confirmed.Found that the mainboard was defective.The device failed to meet specification as it was received or made available for evaluation.The investigation of observed condition isolated the failure to the defective mainboard.No new formal investigation is required, the event will be included in trending and monitoring.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
NELLCOR
Type of Device
OXIMETER
Manufacturer (Section D)
MEDIANA CO. LTD.
1650 1 2 donghwa ri munmak eu
kangwon do wonju si 00000
KR  00000
MDR Report Key9497572
MDR Text Key172257501
Report Number2936999-2019-01042
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 03/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10005941J
Device Catalogue Number10005941J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2019
Date Manufacturer Received03/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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