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

Model Number	4001-9
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: the device has been returned to the local facility but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.
Event or Problem Description
It was reported the sensors stop working.Sometimes they last only 1 hour and sometimes 24 hours.No consequences or impact to patient was reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.The returned senor passed visual inspection; however, failed functional analysis due open infrared in the emitter assembly.Open emitter was most likely due to a failure between bond wire and die attach.A ¿replace sensor" error message displayed; which would have prevented the unit from being able to engage in monitoring activities.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues prior to this reported event.

• Brand Name: RD SET PDT
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7075402
• Report Number: 2031172-2017-01054
• Device Sequence Number: 939064
• Product Code: DQA
• UDI-Device Identifier: 10843997009574
• UDI-Public: 10843997009574
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup

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 Expiration Date: 10/01/2019
• Device Model Number: 4001-9
• Device Catalogue Number: 4001
• Device Lot Number: 16K83
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 01/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1