MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS STRYKER; PULSE OXIMETER SENSOR

Model Number	MAX-N
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Oxygen sensor cord on infant found to have exposed wires.

• Brand Name: STRYKER
• Common Device Name: PULSE OXIMETER SENSOR
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; tempe AZ 85283
• MDR Report Key: 6900067
• Report Number: MW5072510
• Device Sequence Number: 16471971
• Product Code: NLF
• UDI-Device Identifier: 00885825014322
• UDI-Public: 00885825014322
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2017

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 Date: 07/28/2020
• Device Model Number: MAX-N
• Device Lot Number: 6827379
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 DA