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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 MAXFAST
Device Problems Failure to Advance (2524); Contamination /Decontamination Problem (2895)
Patient Problem Tissue Damage (2104)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the device was not recognized and caused stage 1 minor skin injury to the patient.
 
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Brand Name
NELLCOR
Type of Device
OXIMETER
Manufacturer (Section D)
NELLCOR PURITAN BENNETT MEXICO SA
boulevard insurgentes 19030
tijuana 22225
MX  22225
Manufacturer (Section G)
NELLCOR PURITAN BENNETT MEXICO SA
boulevard insurgentes 19030
tijuana 22225
MX   22225
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key8364653
MDR Text Key137052544
Report Number9610849-2019-00005
Device Sequence Number1
Product Code DQA
UDI-Device Identifier10884522039710
UDI-Public10884522039710
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012891
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/22/2019
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
Device Operator Health Professional
Device Model NumberMAXFAST
Device Catalogue NumberMAXFAST
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/28/2019
Initial Date FDA Received02/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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