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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 MAXFASTI
Medical Device Problem Codes Contamination /Decontamination Problem (2895); Material Integrity Problem (2978)
Health Effect - Clinical Code Bruise/Contusion (1754)
Date of Event 10/28/2019
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, during use, the sensor was connected to the patient's forehead and when they shifted the place of the sensor, they found a bruise over the place they had connected the sensor.The patient's forehead got wound.The device had physical damage.
 
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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 Key9379786
Report Number2936999-2019-00973
Device Sequence Number14222464
Product Code DQA
UDI-Device Identifier10884522039697
UDI-Public10884522039697
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K012891
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/26/2019
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 Date09/30/2020
Device Model NumberMAXFASTI
Device Catalogue NumberMAXFASTI
Device Lot Number173030088H
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/01/2019
Initial Report FDA Received Date11/26/2019
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 Other;
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