MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET GE - 12; OXIMETER

Model Number	4085-9
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned cable was evaluated.During evaluation the unit failed visual inspection due to a cut on the outer jacket along the length of the cable; causing exposed kevlar and outer shield.The cable passed continuity tests and was able to obtain readings during preset and simulation testing.The unit was determined to be functioning as designed.
Event or Problem Description
The customer reported on intermittent loss of signal (sensor ruled out as problem) intermittent signal loss throughout case.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Upon further evaluation, it was determined that both the date of event and the date masimo became aware of the event are unknown.Date of event from "(b)(6) 2017".

• Brand Name: RD SET GE - 12
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6840668
• Report Number: 2031172-2017-00854
• Device Sequence Number: 711488
• Product Code: DQA
• UDI-Device Identifier: 00843997009805
• UDI-Public: 00843997009805
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K050252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• 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: 4085-9
• Device Catalogue Number: 4085
• Device Lot Number: 17CQH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 09/03/2017
• Supplement Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1