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

Model Number	4002-9
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.During evaluation, it was found that the returned sensor failed continuity testing due to a damaged flex cable causing an exposed inner shield circuit, and a short between the emitter shield and solder joint assembly.When connected to a philips monitor, a ¿sensor malf" error message is displayed.In this condition the sensor is unable to engage in monitoring activities.A service history record review reveals that this unit was in the field for over two (2) years with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported that when using a comparator device, the readings were "obviously not the real number." the pulse ox continued to scan, but does not successfully read a value when the patient continuously moves.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: 6252859
• Report Number: 2031172-2017-00067
• Device Sequence Number: 13559565
• Product Code: DQA
• UDI-Device Identifier: 10843997009581
• UDI-Public: (01)10843997009581(17)191001(10)16K85
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• 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: 4002-9
• Device Lot Number: 16K85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2016
• Initial Report FDA Received Date: 01/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1