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

Model Number	301-11214
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	01/03/2018
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: OXIMETER, PROBE
• Manufacturer (Section D): XHALE ASSURANCE, INC; 3630 sw 47th ave, suite 100; gainesville FL 32608
• MDR Report Key: 8512561
• Report Number: 3010150334-2019-00002
• Device Sequence Number: 1466129
• Product Code: DQA
• UDI-Device Identifier: B213301112140
• UDI-Public: B213301112140
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 301-11214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 04/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention