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

Model Number 301-11214

Device Problem Missing Information (4053)

Patient Problem Pressure Sores (2326)

Event Date 01/12/2018

Event Type  Injury  

Event Description

Company wasmade aware by one of the residents that the sensor is causing skin breakdown on patients.Three patients were observed where the wounds are now approximately 2-3 weeks old and are healing yet still quite visible with black scabs and its too soon to tell if it will leave scarring.The sensor is just now being implemented throughout the icu's (previously came in through the ed and at times icu staff was able to steal some from the ed).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, PROBED, 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: 8772337
• MDR Text Key: 150432858
• Report Number: 3010150334-2019-00007
• 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: company representative
• Reporter Occupation: Other
• 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
• Date Manufacturer Received: 01/12/2018
• 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