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

Model Number	MAXNJ
Medical Device Problem Codes	Low Readings (2460); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During use, a patient's spo2 value became 90% although the pao2 value exceeded 200.The sensor was replaced then it showed normal value.No patient harm reported.
Additional Manufacturer Narrative
Product was returned for evaluation.Visual inspection did not find anything wrong with the device.The function of the device was tested and it passed all evaluations.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During use, a patient's spo2 value became 90% although the pao2 value exceeded 200.The sensor was replaced then it showed normal value.No patient harm reported.

• Brand Name: NELLCORF
• Common Device Name: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 6831383
• Report Number: 2936999-2017-05434
• Device Sequence Number: 1600327
• Product Code: DQA
• UDI-Device Identifier: 10884522041713
• UDI-Public: 10884522041713
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2017

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: 12/31/2019
• Device Model Number: MAXNJ
• Device Catalogue Number: MAXNJ
• Device Lot Number: 170200068H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1