MAUDE Adverse Event Report: INOVO INC. PURE OXYGEN CONCENTRATOR; PORTABLE OXYGEN CONCENTRATOR

Model Number CH5000

Device Problems Device Inoperable (1663); Electrical Shorting (2926)

Patient Problem No Information (3190)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

The unit was returned to inovo and an investigation is in progress.It appears that the device experienced a surge of input current.This surge of input current created a short on the pcba which disabled the low voltage hardware.As a result, the concentrator was unable to function within product specifications.It is unknown how/if the mechanical damage to the power switch is related to the electrical failure mode (short circuit).The enclosure material has appropriate flame retardance so in the event of this particular failure mode it would be contained.Inovo is submitting this report in an abundance of caution.The intended use of the pure oxygen concentrator is to provide supplemental oxygen to those individuals needing supplemental oxygen therapy.The device is not intended to be life supporting or life sustaining.The device had been in use for over two years when apparently subjected to external high voltage, perhaps lightning.Long-term, oxygen therapy (ltot) is the administration of low flows of supplemental oxygen that traditionally is administered via a nasal cannula.Oxygen therapy in the home is commonly referred to as ltot and not an acute medical intervention, is not life supporting, nor is it life sustaining.Ltot in the home is prescribed for the treatment of stable, moderate to severe chronic hypoxemia in conjunction with chronic lung disease that may be evidenced at rest, with exertion only (oxygen prescribed for use only with exertion) and/or with sleep only (oxygen prescribed only for nocturnal use).Evidence of hypoxemia is based on a room air arterial blood analysis demonstrating a pao2 <55 mmhg or a hemoglobin saturation (sao2) of <88%.Oxygen therapy in the home is intended as a long term, supplemental treatment for which the consistent use of a prescribed flow of oxygen for more than 15 hours per day, over a long period of time may improve life expectancy in certain patient populations with chronic lung disease and hypoxemia.Although commonly prescribed in the us, there is currently no scientific evidence suggesting the use of ltot in the treatment of hypoxemia that occurs only during exertion or sleep has any significant impact on morbidity or mortality.Although oxygen is often prescribed 24 hours per day, the published science and expert guidelines suggest that effective long term oxygen treatment occurs when patients with chronic lung disease and severe hypoxemia experience interruptions in oxygen therapy for up to 8-9 hours of the day.The findings from the 2016 lott study demonstrated that untreated moderate resting desaturation/hypoxemia and moderate-severe exercise/activity related desaturation/hypoxemia does not increase the risk of death or serious injury, as evidence by no difference in survival, acute exacerbation or hospitalization.References: -dunne pj.The clinical impact of new long term oxygen therapy technology.Respir care 2009;54(8):1100-1111 -stoller jk, panos rj, krachman s, doherty de, make b.Oxygen therapy for patients with copd: current evidence and the long term oxygen treatment trial.Chest 2010;138(1):179-187 -ibid.

Event Description

Customer reported sparking and a bad switch with no adverse events or issues ((b)(6) 2017).The customer stated during a follow up that the sparking was near the power switch area, and they could hear the sparks as well.The unit now does not turn on ((b)(6) 2017).

• Brand Name: PURE OXYGEN CONCENTRATOR
• Type of Device: PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): INOVO INC.; 401 leonard blvd, n.; lehigh acres FL 33971
• Manufacturer Contact: marita brust ; 401 leonard blvd. n.; lehigh acres, FL 33971 ; 2396436577
• MDR Report Key: 6752297
• MDR Text Key: 81411457
• Report Number: 1062191-2017-00009
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2017

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: No Information
• Device Model Number: CH5000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1