MAUDE Adverse Event Report: XHALE ASSURANCE, INC NASAL ALAR SPO2 SENSOR; OXIMETER, PROBE, SINGLE USE

Model Number	301-11214
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Upon arrival to the operation room, anesthesia removed pulse oximeter clip from right side of the nose.Pressure ulcer noted under the pulse oximeter clip was a dark reddened area surrounded by black skin.Anesthesia cleaned skin under the clip, and applied a new pulse oximeter to the finger.Progress note reads: pressure ulcer noted under pulse oximeter on right side of nose.Skin appears black with a reddened area.Other notes: patient vital signs: bp normal tensive (diastolic 120-150mmhg); rr tachycardic; temp 99.1 - 100.6 f.Patient on ventilator; bedrest/bedbound on skin precautions (braden score for pressure ulcers scored patient high risk.) there is no additional information is available at this time.This report will be updated if relevant becomes available.

• Brand Name: NASAL ALAR SPO2 SENSOR
• Common Device Name: OXIMETER, PROBE, SINGLE USE
• Manufacturer (Section D): XHALE ASSURANCE, INC; 3630 sw 47th ave, suite 100; gainesville FL 32608
• MDR Report Key: 8772515
• Report Number: 3010150334-2019-00008
• Device Sequence Number: 19343652
• Product Code: DQA
• UDI-Device Identifier: B213301112140
• UDI-Public: B213301112140
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date (Section B): 07/09/2019

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: 09/01/2020
• Device Model Number: 301-11214
• Device Lot Number: TR101737
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3010150334-50819-001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR