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

Model Number	4002-9
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2017
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 the patient was desaturating to 86%, however the patient looked clinically okay.The nurse disconnected & reconnected the rd set inf-l sensor and the inf-l sensor started working.Later in the day with the same probe, another nurse was unable to get a 3-star reading despite repositioning.The patient's o2 saturation was 93% and noted that the sensor is less than 8 hours old.She ended up changing out the probes.This is a problem, because the nurses/customers expect quality readings to displayed as quality 3-star readings on the monitor when perceived correct sensor placement is performed.Sensor was saved and placed in a bag to be sent in for analysis.

• Brand Name: RD SET INF
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6434271
• Report Number: 2031172-2017-00375
• Device Sequence Number: 16379553
• Product Code: DQA
• UDI-Device Identifier: 10843997009581
• UDI-Public: (01)10843997009581(17)200101(10)17A03
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: 4002-9
• Device Catalogue Number: 4002
• Device Lot Number: 17A03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2017
• Initial Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 MO
• Patient Weight: 8