MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET MD20 - 1.5; OXIMETER

Model Number	4102-9
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned cable was evaluated.During evaluation the cable passed all visual and functional testing.The cable was determined to be functioning as designed.
Event or Problem Description
It was reported that "the customer notified masimo cs that they can't seem to get a good confident reading while in flight on the helicopter.They are aware and covering the sensors so light does not interfere.The complaint is that the movement and motion seems to be the problem with the new rd set sensors and cables".No known impact or consequence to patient.

• Brand Name: RD SET MD20 - 1.5
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6378985
• Report Number: 2031172-2017-00296
• Device Sequence Number: 16275588
• Product Code: DQA
• UDI-Device Identifier: 00843997010290
• UDI-Public: (01)00843997010290(11)160801(10)16HXJ
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K050252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• 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: 4102-9
• Device Catalogue Number: 4102
• Device Lot Number: 16HXJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 03/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1