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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: XHALE ASSURANCE, INC NASAL ALAR SPO2 SENSOR; OXIMETER, PROBE, SINGLE USE
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XHALE ASSURANCE, INC NASAL ALAR SPO2 SENSOR; OXIMETER, PROBE, SINGLE USE Back to Search Results
Model Number 301-11214
Device Problem Missing Information (4053)
Patient Problem Pressure Sores (2326)
Event Date 11/17/2017
Event Type  Injury  
Event Description
Facility had two patients that have had suspected pressure issues related to the sensor.Could not confirm that sites were being rotated every 12 hours as recommended.There is no additional information is available at this time.This report will be updated if relevant becomes available.
 
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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, suite 100
gainesville, FL 32608
3523718488
MDR Report Key8771513
MDR Text Key150404724
Report Number3010150334-2019-00005
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171423
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number301-11214
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/17/2017
Initial Date FDA Received07/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number3010150334-50819-001-C
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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