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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 D-YS
Medical Device Problem Code Low Readings (2460)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/15/2018
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, the unit gave low readings with pediatric sensors.The customer reported that the unit often took 45-60 seconds or more to read and readings were low (92-93 with good waveforms) when the saturation should be 98-99.This low readings have come in several kids with no reason to have a low pulse, i.E.Warm feet, no fevers and no respiratory illnesses.It was indicated that there was no patient outcome abnormalities.
 
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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 Key7912174
Report Number2936999-2018-00613
Device Sequence Number19297638
Product Code DQA
UDI-Device Identifier20884522042540
UDI-Public20884522042540
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K012891
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/26/2018
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 NumberD-YS
Device Catalogue NumberD-YS
Device Lot Number171390319H
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/04/2018
Initial Report FDA Received Date09/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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