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

Model Number	4050
Medical Device Problem Codes	Incorrect Measurement (1383); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.
Event or Problem Description
The customer reported an interruption of patient monitoring and an extended period of time before the spo2 begins to read.Per the customer, when it does begin to read, it starts very low and then takes an extended time to come up to the expected spo2.The spo2 will then randomly drop-out again with the same behavior as start-up.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, additional manufacturing narrative (if other): the returned sensor was evaluated.No external physical damage was observed.The sensor failed continuity testing due to multiple broken traces inside the rd15 connector causing multiple open connections.The sensor was connected to a monitor and was unable to obtain readings, the sensor led did not illuminate., corrected data: model # was corrected from 4085-9 to 4050, lot# was corrected from 16jvg to e16jps, catalog # was corrected from 4085 to 4050, udi# corrected from (b)(4) to (b)(4).Corrected from k051212 to k042536.Corrected from 09/09/2016 to 09/01/2016.Corrected from a blank field to rd set ge-12.

• Brand Name: RD SET DCI
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6341919
• Report Number: 2031172-2017-00231
• Device Sequence Number: 16534898
• Product Code: DQA
• UDI-Device Identifier: 00843997009805
• UDI-Public: (01)00843997009805(11)160901(10)16JVG
• 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: Nurse
• 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 Model Number: 4050
• Device Catalogue Number: 4050
• Device Lot Number: E16JPS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 01/29/2017
• Supplement Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1