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 04/30/2018

Event Type  Injury  

Event Description

Facility reported the sensor had caused two pressure ulcers.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: 8772671
• MDR Text Key: 150442605
• Report Number: 3010150334-2019-00010
• 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: Other Health Care Professional
• 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: 04/30/2018
• 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