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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FREEDOM MEDICAL; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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FREEDOM MEDICAL; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING Back to Search Results
Model Number FREEDOM TAG 138456 1000016252
Device Problem Key or Button Unresponsive/not Working (4063)
Patient Problem Low Oxygen Saturation (2477)
Event Date 12/05/2020
Event Type  malfunction  
Event Description
Nurse asked me to enter room to check bipap, which was alarming with desaturation to 88.Readjusted mask and reduced leak and volumes improved and spo2 increased to 98.Attempted to reset alarms and none of the keys would work.Was unable to reset.Took patient off and performed the exhalation port check which passed, but again unable to depress any of the keys to return to previous settings.This rendered the bipap inoperable.Manually provided oxygen via resuscitation unit while nurse secured a high flow oxygen cannula.Set up patient on high flow nasal cavity (hfnc) 15 liter with spo2 98 while another bipap was secured.Patient currently remains on hfnc-15 with new bipap in the room.
 
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Type of Device
VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
Manufacturer (Section D)
FREEDOM MEDICAL
219 welsh pool road
exton PA 19341
MDR Report Key11010389
MDR Text Key221488665
Report Number11010389
Device Sequence Number1
Product Code MNS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFREEDOM TAG 138456 1000016252
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/11/2020
Event Location Hospital
Date Report to Manufacturer12/15/2020
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age19345 DA
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