MAUDE Adverse Event Report: CAIRE INC. STROLLER; PORTABLE, LIQUID OXYGEN

Model Number 10845200

Device Problems Fire (1245); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/03/2021

Event Type  Death  

Manufacturer Narrative

Caire is contacting the initial reporter of the incident ((b)(4)) to gather more information about the incident, and well as to coordinate the return of the units for an evaluation, if possible.The three devices (2 liberators, 1 stroller) present at the scene of the incident are currently in police custody.If any new information is discovered, a follow-up report will be submitted.

Event Description

A fire occurred in the apartment of a medical lox patient.The fire brigade entered the apartment with respiratory equipment and brought the patient out of the apartment.The emergency rescue service gave first aid and the patient was brought to the hospital, where he passed away.There was a call to the (b)(4) emergency number before the accident.A person reported that the portable (side fill) is frozen on the filling connector of the liberator.The person was instructed according to the user manual and with safety advice.The patient was delivered with lox since 2012.Two liberator devices and a stroller were present at the scene of 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.Two of the three devices present at the scene of the incident were returned to caire for an evaluation.The liberator (s/n (b)(6)) is in police custody and was not returned to caire.The evaluation, conducted by caire personnel, of the returned liberator 45 stationary liquid oxygen reservoir (s/n (b)(6)) and stroller liquid oxygen portable unit (s/n (b)(6)) could not find the root cause of the adverse event.Both the reservoir and the portable unit sustained substantial fire damage and were deemed non-functional and not suitable for any functional testing.Only a visual inspection of the test units could be conducted.A separate investigation conducted by austrian authorities stated that the fire was due user negligence.They specified that the fire was very likely the result of smoking in conjunction with the use of medicated oxygen.

• Brand Name: STROLLER
• Type of Device: PORTABLE, LIQUID OXYGEN
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• MDR Report Key: 12076136
• MDR Text Key: 258664877
• Report Number: 3004972304-2021-00015
• Device Sequence Number: 1
• Product Code: BYJ
• Combination Product (y/n): N
• PMA/PMN Number: K800742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10845200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death