MAUDE Adverse Event Report: DIRECT SUPPLY MANUFACTURING, INC. DIRECT SUPPLY 5-LITER OXYGEN CONCETRATOR; GENERATOR, OXYGEN, PORTABLE

Device Problems No Audible Alarm (1019); Disconnection (1171)

Patient Problem Respiratory Arrest (4461)

Event Date 06/13/2022

Event Type  Death  

Event Description

My husband was on an oxygen concentrator that was prescribed and had been for many years.Lincare replaced his concentrator with a new one (different brand) around (b)(6) i think.Typically all the concentrators in the past have had an alarm go off if there is an issue and we have been able to resolve it.Prior to bed all lines are checked to make sure everything is fine.On the morning of (b)(6) i woke up to find the line connected to the concentrator had come off and no alarm sounded, the yellow light was on and my husband was not breathing.I started chest compressions and yelled at my mom to call the paramedics.They arrived, declared my husband dead at 7:59 am per his death certificate which is the exact time my mom called the paramedics.We saw two beeps on their monitor after they hooked him up then a flat line.They didn't even try to revive him.They were informed of the condition of the oxygen concentrator and just made a phone call but i don't know to whom.I called lincare to ask them what happened to the concentrator, why did the alarm not go off and how in the world did the hose come off.I was advised that this concentrator should have never been issued to my husband because it is not a good concentrator.I want to know what the heck happened.My husband is dead and that machines alarm never sounded off.They did test the machine back at the office and said no issue was found.I have pictures of the machine in his cell phone but this was after they disconnected it.He was sent directly to the mortuary no exam of any kind was done on him by anyone other then the paramedics who didn't even want to touch him and all they did was stick things on him for a reading.Fda safety report id# (b)(4).

• Brand Name: DIRECT SUPPLY 5-LITER OXYGEN CONCETRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): DIRECT SUPPLY MANUFACTURING, INC.; 6635 west champions way; milwaukee WI 53223
• MDR Report Key: 15001817
• MDR Text Key: 295870373
• Report Number: MW5110810
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: INSULIN DEXCOM G6, I DON'T KNOW WHAT ALL MEDS HE TOOK.; TOO MANY MEDS TO LIST
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White