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

Model Number 301-11214

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 12/20/2017

Event Type  Injury  

Event Description

Nurse reported skin breakdown associated with sensor.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: 8771577
• MDR Text Key: 150413958
• Report Number: 3010150334-2019-00006
• Device Sequence Number: 1
• Product Code: DQA
• 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 Model Number: 301-11214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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