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

Model Number	4235
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturing narrative: other, additional manufacturing narrative (if other): the device has been returned to the local facility but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.
Event or Problem Description
While removing o3 sensors for baby wash care, the nurse found skin necrosis under both o3 sensors.Necrosis are located under the del emitter and receptors.
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed., corrected data: udi # corrected from: (b)(4).

• Brand Name: O3 PEDIATRIC SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6716550
• Report Number: 2031172-2017-00728
• Device Sequence Number: 964504
• Product Code: MUD
• UDI-Device Identifier: 10843997010020
• UDI-Public: 10843997010020
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K160526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: 4235
• Device Catalogue Number: 4235
• Device Lot Number: 17CRV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 07/16/2017
• Supplement Report FDA Received Date: 08/29/2017
• 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
• Patient Age: 5 MO
• Patient Weight: 4