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

Model Number 301-11214

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 01/03/2018

Event Type  Injury  

Event Description

During in-service training for the proper placement, securement, and the need to check and rotate the sensor; a member of the nursing staff realized that a sensor on a patient had not been checked.The patient was evaluated and skin under the sensor had become visibly purple in color.The nurse suggested her best guess was that the sensor had been in place for several days.The patient was re-evaluated later in the evening and the site had turned noticeably darker with some thickening of the surface.The risk management department for the hospital was later contacted to obtain additional information.They were unable to locate any reports regarding this event.No additional information is available from the healthcare facility at this time.This report will be updated if relevant information becomes available.

• Brand Name: NASAL ALAR SPO2 SENSOR
• Type of Device: OXIMETER, PROBE
• 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: 8512561
• MDR Text Key: 141905752
• Report Number: 3010150334-2019-00002
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2019
• 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: 01/03/2018
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention