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

Model Number	MAXA
Medical Device Problem Code	False Reading From Device Non-Compliance (1228)
Health Effect - Clinical Codes	Respiratory Distress (2045); 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, while using the device on the patient, spo2 (peripheral capillary oxygen saturation) was alarming, the pulse oximetry was in the 70¿s in parenthesis and good weight form.The patient was in bed for 5 days with spo2 form ranging 90% to 100%.A new sensor was placed on the patient and prior one had fallen off at 1400 degrees.The monitor alarmed with good weight form and patient was on respiratory distress and new sensor read 100% with same weight form with faulty one.There was patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, while using the device on the patient sp02 was alarming, the pulse oximetry was in the 70's in parenthesis and good weight form.The patient was in bed for 5 days with spo2 form ranging 90% to100%.A new spo2 sensor was placed on the patient and prior one, it had fallen off at 1400 degrees.The monitored alarmed with good weight form and patient was on respiratory distress and new sensor read 100% with same weight form with faulty one.There was no patient injury.

• 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: 7542302
• Report Number: 1282497-2018-00412
• Device Sequence Number: 19300657
• Product Code: DQA
• UDI-Device Identifier: 20884522040089
• UDI-Public: 20884522040089
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/21/2018

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: 01/31/2021
• Device Model Number: MAXA
• Device Catalogue Number: MAXA
• Device Lot Number: 180470269H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 08/21/2018
• 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: Required Intervention