MAUDE Adverse Event Report: MASIMO - 40 PARKER O3 LARGE SENSOR; OXIMETER

Model Number	3756
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Attempts for the return of the product as well as additional information requests have been made in order to identify the product involved in the reported event.The customer indicated that the product used for this event was discarded and the lot/serial number was not available.If new information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that the o3 sensor emitters and detector are too rounded, and protrude far enough out that causes skin indentations, the attached pictures are examples of 20 seconds of light pressure applied evenly on the sensor.This was noted by us, no customer complaint from the attached picture.I don¿t have pictures of the actual patient skin, however, the customer complained that this will be an issue for his patients.There was no reference made or information given by the customer, on which specific patient this happened.We couldn¿t follow up.Picture attached is from another patient, where no complaint was made, but we noticed indentations left on the skin.His concern was specifically for prone patients and for beach chair applications, where the forehead is strapped and pinned against the back cushion for stability.Same thing on the prone patients.No known impact or consequence to patient.

• Brand Name: O3 LARGE SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6420754
• Report Number: 2031172-2017-00363
• Device Sequence Number: 603187
• Product Code: DQA
• UDI-Device Identifier: 10843997008416
• UDI-Public: (01)10843997008416(17)200101(10)17ACW
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K160526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 3756
• Device Catalogue Number: 3756
• Device Lot Number: 17ACW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other