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

Model Number	MAXA
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the unit had low readings that did not correlate to patient's blood gasses.It was stated that patient was getting normal sat readings and abruptly dropped to 60s and 70s which led to over treating patient.They swapped the sensors, cables and multi measurement servers with no change.The spo2 was low compared to abg's using other device.There was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.The device met specifications as it was made available for evaluation.It was noted that there was no failure or defect of the product.There was no cause of failure since the investigation found the product to function normally.Information has been added to the database and trends will continue to be monitored.The product was not related to the reported complaint as no issue was identified.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 22225 ; MX 22225
• MDR Report Key: 9131682
• Report Number: 2936999-2019-00800
• Device Sequence Number: 16709890
• Product Code: DQA
• UDI-Device Identifier: 20884522040089
• UDI-Public: 20884522040089
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K012891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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 Model Number: MAXA
• Device Catalogue Number: MAXA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1