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

Model Number	4087-9
Medical Device Problem Codes	Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2017
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
It was reported that "customer wiggled the cable nearest the spacelab connection, the probe stops reading".No known impact or consequence to patient was reported.
Additional Manufacturer Narrative
The returned cable was evaluated.During inspection, the cable passed visual analysis and software testing; however, failed functional analysis due to a short between the resistor and shield can (outer shield) inside the spacelabs connector.A "sensor off patient - check connection at patient" 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 six (6) months with no previous reported issues prior to this reported event.(b)(4).

• Brand Name: RD SET SL - 12
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6546369
• Report Number: 2031172-2017-00544
• Device Sequence Number: 13736782
• Product Code: DQA
• UDI-Device Identifier: 00843997010559
• UDI-Public: 00843997010559
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Biomedical Engineer
• 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: 4087-9
• Device Catalogue Number: 4087
• Device Lot Number: 16NHK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 05/04/2017
• 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