STRYKER MAX N PULSE OXIMETER SENSOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-11 for STRYKER MAX N PULSE OXIMETER SENSOR manufactured by .

MAUDE Entry Details

Report NumberMW5089728
MDR Report Key9007958
Date Received2019-09-11
Date of Report2019-09-09
Date Added to Maude2019-09-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameSTRYKER MAX N PULSE OXIMETER SENSOR
Generic NameOXIMETER, REPROCESSED
Product CodeNLF
Date Received2019-09-11
Lot Number125807774
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0

Device Sequence Number: 2

Brand NameSTRYKER MAX N PULSE OXIMETER SENSOR
Generic NameOXIMETER, REPROCESSED
Product CodeNLF
Date Received2019-09-11
Lot Number125082650
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0

Device Sequence Number: 3

Brand NameSTRYKER MAX N PULSE OXIMETER SENSOR
Generic NameOXIMETER, REPROCESSED
Product CodeNLF
Date Received2019-09-11
Lot Number124867323
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0

Device Sequence Number: 4

Brand NameSTRYKER MAX N PULSE OXIMETER SENSOR
Generic NameOXIMETER, REPROCESSED
Product CodeNLF
Date Received2019-09-11
Lot Number123878555
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No4
Device Event Key0

Device Sequence Number: 5

Brand NameSTRYKER MAX N PULSE OXIMETER SENSOR
Generic NameOXIMETER, REPROCESSED
Product CodeNLF
Date Received2019-09-11
Lot Number127631354
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No5
Device Event Key0

Device Sequence Number: 6

Brand NameSTRYKER MAX N PULSE OXIMETER SENSOR
Generic NameOXIMETER, REPROCESSED
Product CodeNLF
Date Received2019-09-11
Lot Number126176415
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No6
Device Event Key0

Device Sequence Number: 7

Brand NameSTRYKER MAX N PULSE OXIMETER SENSOR
Generic NameOXIMETER, REPROCESSED
Product CodeNLF
Date Received2019-09-11
Lot Number126176416
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No7
Device Event Key0

Device Sequence Number: 8

Brand NameSTRYKER MAX N PULSE OXIMETER SENSOR
Generic NameOXIMETER, REPROCESSED
Product CodeNLF
Date Received2019-09-11
Lot Number125428342
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No8
Device Event Key0

Device Sequence Number: 9

Brand NameSTRYKER MAX N PULSE OXIMETER SENSOR
Generic NameOXIMETER, REPROCESSED
Product CodeNLF
Date Received2019-09-11
Lot Number116839702
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No9
Device Event Key0

Device Sequence Number: 10

Brand NameSTRYKER MAX N PULSE OXIMETER SENSOR
Generic NameOXIMETER, REPROCESSED
Product CodeNLF
Date Received2019-09-11
Lot Number125428543
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No10
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-11

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