MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET MD14-12; OXIMETER

Model Number	4081-9
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacuring 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 "call today from (b)(6) , bio-med at (b)(6).Asked if our shielding of the rd cables is the same as the lnop cable they previously used.The nicu transport team said the sp02 reading dropped out or had periodic reading when the helicopter takes off and works fine as soon as the helicopter lands.This has occurred only once that (b)(6) is aware of.The monitor used in the transporter is a welch allyn propaq with a rd set md14 ¿ 12 cable.(b)(6) has to dismantle the transporter to get to the welch allyn monitor.He said i could pick up the cable on thurs".No known impact or consequence to patient.
Additional Manufacturer Narrative
The returned cable was evaluated.During evaluation the cable passed all visual and functional testing.The cable was determined to be functioning as designed.A service history record review reveals that this lot was in the field for over four (4) months with no previous reported issues prior to this reported event, corrected data.

• Brand Name: RD SET MD14-12
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6417137
• Report Number: 2031172-2017-00360
• Device Sequence Number: 11006619
• Product Code: DQA
• UDI-Device Identifier: 00843997009768
• UDI-Public: (01)00843997009768(11)161201(10)16N1K
• 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
• 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: 4081-9
• Device Catalogue Number: 4081
• Device Lot Number: 16N1K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2017
• Supplement Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1