MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC. DEVILBISS 5 LITER OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number 525DS

Device Problems Product Quality Problem (1506); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

Event Description

Delay of therapy; devilbiss 5 liter oxygen concentrator was purchased on line, from (b)(4) on (b)(6) 2021 to replace a rental concentrator of the same make and model.Web site faq's specified all devices were new.The device was received a week latter and the rental was returned the same day.(note concentrator supplies supplemental o2 for sleep apnea therapy).It was noted that the device had a rental label stating device was property of (b)(4) upon receipt.When powered up, device was extremely loud and within 30 minutes of operation, a low o2 alarm illuminated with an audible alarm.Device was powered down and filter cover was opened and it was observed that the intake bactria filter was so dirty that it was blocking air flow.Additionally a run time indicator with in the filter area specified the device had operated 21161 hours which indicates the device is used and not new as stated in the website faq.However there was no labeling specifying the device was used or recondition.New bacterial filter was purchased and replaced which did quit the device substantially, however, the low oxygen indicator with audible signal did alarm following 30 minutes of operation.There have been multiple attempt to contact cpap supply usa service, however there has been no response.End user financed the device through cpap supply usa and due to the monthly required payment, renting a second device is not an option.Currently patient is not receiving supplemental oxygen therapy.If seller had declared that the device had been used for 21161 hours and was in fact not new, or even reconditioned, end user would not of purchased the device.It should be noted (b)(4) did require a current prescription to purchased an unusable device.Fda safety report id# (b)(4).

• Brand Name: DEVILBISS 5 LITER OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC.
• MDR Report Key: 12878052
• MDR Text Key: 281507398
• Report Number: MW5105589
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 525DS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2021
• Patient Sequence Number: 1
• Treatment: ABILIFY; AMLODIPINE ; CELEBREX; CRESTOR; CYMBALTA; DESYREL ; LAMICTAL
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White