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 11/21/2017

Event Type  Injury  

Event Description

Cardiothoracic patient, multiple drips in the operation room for 10 hours.The nurses are doing every 2 hour position changes with them.Anesthesia is using them and not doing any repositioning of them while in the operating room.In the past month there have been 3 patients with 4 deep tissue injuries.One patient had one on each nostril.All of the patients had long operating room times, lvad's or ecmo's.All on multiple pressers.No additional information is available at this time.This report wil be updated if relevant information 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: 8769486
• MDR Text Key: 150375386
• Report Number: 3010150334-2019-00004
• 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: Notification
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 301-11214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 3010150334-50819-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention