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

Model Number	4001-9
Medical Device Problem Codes	Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.During inspection, the sensor passed visual analysis and software testing; however, failed functional analysis due to open red in the emitter assembly.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 lot was in the field for over seven (7) months with no previous reported issues prior to this reported event.
Event or Problem Description
It was reported that the customer was experiencing signal loss during monitoring.Per the report: contacted by (b)(6) in bio-med that the or dept.Was experiencing signal loss during cases in the or.Staff had disconnected cables & sensor and it began to work.I went in today and we started with the sensor and it wasn't working, changed out the sensor and it began to work.I have collected that sensor and instructed them to hold onto any others that quit working.If they change sensor and it still doesn't work also left rd adapter cable replacement.These are draeger delta anesthesia monitors with masimo module, rd adapter cables using adult & infant disposable rd sensors.

• Brand Name: RD SET ADT
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6695840
• Report Number: 2031172-2017-00698
• Device Sequence Number: 1760345
• Product Code: DQA
• UDI-Device Identifier: 10843997009574
• UDI-Public: 10843997009574
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K042346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• 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: 4001-9
• Device Catalogue Number: 4001
• Device Lot Number: 16MPA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1