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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; OXIMETER
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NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; OXIMETER Back to Search Results
Model Number DS100A
Medical Device Problem Code Failure to Sense (1559)
Health Effect - Clinical Code Injury (2348)
Date of Event 05/15/2018
Type of Reportable Event Serious Injury
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 stopped providing reading of spo2 (peripheral capillary oxygen saturation) value.It was stated that the nurse checked the part where the sensor was applied and confirmed bleeding on the edge of the patient's nail.
 
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
NELLCOR
Common Device Name
OXIMETER
Manufacturer (Section D)
NELLCOR PURITAN BENNETT MEXICO SA
boulevard insurgentes 19030
tijuana 22225
MX  22225
MDR Report Key7534719
Report Number2936999-2018-00357
Device Sequence Number152186
Product Code DQA
UDI-Device Identifier10884521129474
UDI-Public10884521129474
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K012891
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberDS100A
Device Catalogue NumberDS100A
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/16/2018
Supplement Date Received by Manufacturer05/16/2018
Initial Report FDA Received Date05/22/2018
Supplement Report FDA Received Date06/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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