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

Model Number	D-YS
Medical Device Problem Codes	Image Display Error/Artifact (1304); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during procedure, the device was not working with system failure 010.When it was attached to the disposable sensor it worked fine.The patient wear the device to track oxygen desaturation while sleeping but inaccurate readings resulted in failing to alert when the oxygen levels were low.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The reported event was not confirmed.The sample returned passed all functional tests required for this product.No corrective actions will be taken at this moment based on the conclusions of the investigation.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana,co 22225 ; MX 22225
• MDR Report Key: 9210744
• Report Number: 2936999-2019-00879
• Device Sequence Number: 10875030
• Product Code: DQA
• UDI-Device Identifier: 20884522042540
• UDI-Public: 20884522042540
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K012891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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 Model Number: D-YS
• Device Catalogue Number: D-YS
• Device Lot Number: 190670223H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 04/16/2020
• 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: Life Threatening; Other