MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; OXIMETER

Model Number	SC-NEO
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/11/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A customer contacted us regarding a product, pulse ox (oximeter) bedside monitor.The customer found their infant child unresponsive.The infant was later pronounced deceased by medical professionals.The infant was connected to a pulse oximeter with a sensor.There were no error codes displayed on the monitor.The patient was also connected to a ventilator.The lot number of the sensor was not recorded and will not be returned.The monitor has been sent back to the service center in plainfield, in for failure investigation.
Additional Manufacturer Narrative
The incident sensor was not returned for evaluation.The concomitant pm100n bedside sp02 monitor was returned and nothing was found during testing that would have contributed to the reported event.Alarms functioned normally when alarm limits were violated and the unit tested satisfactorily.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A customer contacted us regarding a product, pulse ox (oximeter) bedside monitor.The customer found their infant child unresponsive.The infant was later pronounced deceased by medical professionals.The infant was connected to a pulse oximeter with a sensor.There were no error codes displayed on the monitor.The patient was also connected to a ventilator.The lot number of the sensor was not recorded and will not be returned.The monitor has been sent back to the service center in (b)(4) for failure investigation.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 7479158
• Report Number: 1282497-2018-00327
• Device Sequence Number: 1314761
• Product Code: DQA
• UDI-Device Identifier: 20884522042434
• UDI-Public: 20884522042434
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K030930
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2016
• Device Model Number: SC-NEO
• Device Catalogue Number: SC-NEO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 11 MO
• Patient Weight: 7