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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 D25L
Medical Device Problem Code Low Readings (2460)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/12/2018
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 device's spo2 level was lower than the readings provided with sensor.There was no patient injury.
 
Additional Manufacturer Narrative
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 Key8047517
Report Number9610849-2018-00050
Device Sequence Number19246109
Product Code DQA
UDI-Device Identifier10884522042505
UDI-Public10884522042505
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K162014
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/20/2018
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 Expiration Date05/31/2021
Device Model NumberD25L
Device Catalogue NumberD25L
Device Lot Number181660218H
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/12/2018
Supplement Date Received by Manufacturer11/26/2018
Initial Report FDA Received Date11/07/2018
Supplement Report FDA Received Date12/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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