MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET NEOPT; OXIMETER

Model Number	4004
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.
Event or Problem Description
It was reported that a desaturation was noted by masimo clinical specialist while discussing troubleshooting with rn.The patient appeared pink and not in any distress while in bed.Sensor applied according to the dfus to the baby's left foot.During the time of the desat, the pr remained the same (matching with ecg) (ge monitor in use 12 sec avg time, normal sensitivity).The pleth was completely full of artifact.Spo2 decreased to 83%, then back up to 100% within 3 seconds.The same exact event reoccurred less than 2 minutes later.No known impact or consequence to patient was reported.

• Brand Name: RD SET NEOPT
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6596238
• Report Number: 2031172-2017-00597
• Device Sequence Number: 13534088
• Product Code: DQA
• UDI-Device Identifier: 10843997009604
• UDI-Public: (01)10843997009604(17)191101(10)16MNZ
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial

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: 4004
• Device Catalogue Number: 4004
• Device Lot Number: 16MNZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 05/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1