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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIBERATOR; STATIONARY, LIQUID OXYGEN
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LIBERATOR; STATIONARY, LIQUID OXYGEN Back to Search Results
Model Number 13262253
Device Problems Fire (1245); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  Death  
Manufacturer Narrative
The unit is in police custody.Caire is attempting to coordinate the return of the unit for an evaluation and gather additional information about the incident.If any new information is discovered, a follow-up report will be submitted.
 
Event Description
On tuesday, (b)(6), an accident involving a fire and explosion happened at the home of a patient using home lox since (b)(6) 2019.One of five reservoirs present, a liberator 45, was burned and taken by the police for further investigation.No additional information is currently available about the cause of the accident.The patient passed away following the incident.
 
Manufacturer Narrative
Pursuant to title 21 - food and drugs, chapter i - food and drug administration department of health and human services, subchapter h -0 medical device, part 803 - medical device reporting, subpart a - general provisions, section 803.16, neither this report nor any information submitted herein constitutes an admission by caire inc.That the device stated in this report, caire inc., or caire inc.'s employees, caused or contributed to the reportable event stated herein.The unit has been returned from policy custody to the customer.Caire is attempting to coordinate the return of the unit for an evaluation and gather additional information about the incident.If any new information is discovered, a follow-up report will be submitted.
 
Manufacturer Narrative
Pursuant to title 21 - food and drugs, chapter i - food and drug administration department of health and human services, subchapter h -0 medical device, part 803 - medical device reporting, subpart a - general provisions, section 803.16, neither this report nor any information submitted herein constitutes an admission by caire inc.That the device stated in this report, caire inc., or caire inc.'s employees, caused or contributed to the reportable event stated herein.Rimkus consulting, a third-party consulting company, completed an investigation of the unit.Below is a summary of the conclusions in the test report: 1.The first item ignited, ignition source, and cause of the fire cannot be established based on criteria and guidelines of nfpa 921 - guide for fire and explosion investigations.2.Significant information and details regarding the scene are unavailable to interpret and confirm the origin of the fire with respect to the appliance, eliminate other possible sources of competent ignition, or conclusively identify the cause of the fire.3.While the evidence is insufficient to identify the origin or cause of the fire, the liberator 45 that was examined revealed no evidence of internal failure related to the fire's cause.Significant information and details regarding the scene itself were unavailable from the fire service or the police to interpret and confirm the cause and the origin of the fire.While the available evidence is insufficient to conclusively identify the origin or cause of the fire, the unit examined did not indicate evidence of catastrophic failure, nor exhibit evidence of being the source of the fire or explosion.
 
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Brand Name
LIBERATOR
Type of Device
STATIONARY, LIQUID OXYGEN
MDR Report Key11100581
MDR Text Key224556899
Report Number3004972304-2020-00037
Device Sequence Number1
Product Code BYJ
Combination Product (y/n)N
PMA/PMN Number
K800742
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup,Followup
Report Date 05/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number13262253
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2021
Date Manufacturer Received12/03/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
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