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

Model Number	2696
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple attempts for product return and requests for additional information were made.The product has not been returned to masimo to allow an analysis to be performed.If new information is obtained or the product is returned, a follow up report will be submitted.
Event or Problem Description
The customer reported: "intermittently losing signal." no patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.During inspection, the sensor failed visual analysis due to a torn outer jacket at the bend relief area of the m15 connector.Eeprom content verification did not identify any issues.The sensor failed continuity testing due to an open connection in the cable on the emitter circuit at the torn outer jacket area.When the sensor was connected to a masimo monitoring device, the device was able to generate a "check sensor connection" error message.Corrected data: lot# was updated from "a6j177" to "k16jp1".Model# was updated from "23953" to "2696".Device manufacture date was updated from "09/21/2016" to "09/29/2016".

• Brand Name: RAINBOW DCI
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7224037
• Report Number: 2031172-2018-00030
• Device Sequence Number: 984033
• Product Code: DQA
• UDI-Device Identifier: 00843997004855
• UDI-Public: 00843997004855
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K080238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Emergency Medical Technician
• 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: 2696
• Device Catalogue Number: 2696
• Device Lot Number: K16JP1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 01/28/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RC-4 CABLE