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 Number: MW5089728
• MDR Report Key: 9007958
• Date Received: 2019-09-11
• Date of Report: 2019-09-09
• Date Added to Maude: 2019-09-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: STRYKER MAX N PULSE OXIMETER SENSOR
• Generic Name: OXIMETER, REPROCESSED
• Product Code: NLF
• Date Received: 2019-09-11
• Lot Number: 125807774
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0

Device Sequence Number: 2

• Brand Name: STRYKER MAX N PULSE OXIMETER SENSOR
• Generic Name: OXIMETER, REPROCESSED
• Product Code: NLF
• Date Received: 2019-09-11
• Lot Number: 125082650
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0

Device Sequence Number: 3

• Brand Name: STRYKER MAX N PULSE OXIMETER SENSOR
• Generic Name: OXIMETER, REPROCESSED
• Product Code: NLF
• Date Received: 2019-09-11
• Lot Number: 124867323
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0

Device Sequence Number: 4

• Brand Name: STRYKER MAX N PULSE OXIMETER SENSOR
• Generic Name: OXIMETER, REPROCESSED
• Product Code: NLF
• Date Received: 2019-09-11
• Lot Number: 123878555
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0

Device Sequence Number: 5

• Brand Name: STRYKER MAX N PULSE OXIMETER SENSOR
• Generic Name: OXIMETER, REPROCESSED
• Product Code: NLF
• Date Received: 2019-09-11
• Lot Number: 127631354
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0

Device Sequence Number: 6

• Brand Name: STRYKER MAX N PULSE OXIMETER SENSOR
• Generic Name: OXIMETER, REPROCESSED
• Product Code: NLF
• Date Received: 2019-09-11
• Lot Number: 126176415
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 6
• Device Event Key: 0

Device Sequence Number: 7

• Brand Name: STRYKER MAX N PULSE OXIMETER SENSOR
• Generic Name: OXIMETER, REPROCESSED
• Product Code: NLF
• Date Received: 2019-09-11
• Lot Number: 126176416
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 7
• Device Event Key: 0

Device Sequence Number: 8

• Brand Name: STRYKER MAX N PULSE OXIMETER SENSOR
• Generic Name: OXIMETER, REPROCESSED
• Product Code: NLF
• Date Received: 2019-09-11
• Lot Number: 125428342
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 8
• Device Event Key: 0

Device Sequence Number: 9

• Brand Name: STRYKER MAX N PULSE OXIMETER SENSOR
• Generic Name: OXIMETER, REPROCESSED
• Product Code: NLF
• Date Received: 2019-09-11
• Lot Number: 116839702
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 9
• Device Event Key: 0

Device Sequence Number: 10

• Brand Name: STRYKER MAX N PULSE OXIMETER SENSOR
• Generic Name: OXIMETER, REPROCESSED
• Product Code: NLF
• Date Received: 2019-09-11
• Lot Number: 125428543
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 10
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-09-11