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

Model Number	4002-9
Medical Device Problem Codes	Incorrect Measurement (1383); Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation it was found that the sensor life has expired per patient monitoring time.The sensor passed continuity testing; no open connections or shorts were detected.When connected to a known good philips monitor the sensor displayed a ¿replacesensr" error message.The sensor was determined to be functioning as designed.
Event or Problem Description
The customer reported when the sensor is first connected everything works fine for 30-120 minutes; then the reading "goes away." the customer would disconnect and reconnect the sensor to get the reading back, but this strategy no longer worked.It was also indicated that the sensor readings would fluctuate significantly lower to higher and then stabilize.Readings would drop down into the 70's before migrating back up and stabilizing into the mid 90's.No consequences or impact to patient were reported.

• Brand Name: RD SET INF
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6325655
• Report Number: 2031172-2017-00192
• Device Sequence Number: 694324
• Product Code: DQA
• UDI-Device Identifier: 10843997009581
• UDI-Public: (01)10843997009581(17)191001(10)16KJU
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other
• 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: 16KJU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2017
• Initial Report FDA Received Date: 02/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1