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

Model Number 301-11214

Device Problem Missing Information (4053)

Patient Problem Pressure Sores (2326)

Event Date 02/13/2018

Event Type  Injury  

Event 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
• Type of Device: OXIMETER, PROBE, SINGLE USE
• Manufacturer (Section D): XHALE ASSURANCE, INC; 3630 sw 47th ave, suite 100; gainesville FL 32608
• Manufacturer (Section G): XHALE ASSURANCE, INC; 3630 sw 47th ave, suite 100; gainesville FL 32608
• Manufacturer Contact: jeffrey hoebelheinrich ; 3630 sw 47th ave, suite 100; gainesville, FL 32608 ; 3523718488
• MDR Report Key: 8772515
• MDR Text Key: 150529772
• Report Number: 3010150334-2019-00008
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: B213301112140
• UDI-Public: B213301112140
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: 301-11214
• Device Lot Number: TR101737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3010150334-50819-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR