MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; OXYGEN CONCENTRATOR

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

A voluntary medwatch report, mw5078382, was received on (b)(6) 2018 by mail.The initial reporter stated "this is a safety concern.The unit fails to monitor oxygen to the pt.After further checking i found that none of the following manufactured oxygen concentrators monitored the oxygen to the pt; inogen, phillips, invacare, drive, inogen was also found to not restart after a power failure.This can cause a pt to unknowingly go without oxygen.I recommend that all machines be recalled and fixed and not used until this safety concern is solved".There is no model information for the devilbiss concentrator.The devilbiss items that were reported, all coded caw, which are "portable oxygen concentrator'.No specific product model is identified in this repot, devilbiss manufacturers the igo (306), 525 and 1025 series devices.Regarding the comment on lack of monitoring feature on the oxygen concentrators, a typical continuous flow stationary concentrator does not directly monitor oxygen to a patient, this is done indirectly through a few mechanisms: * alerts and alarms for concentrator operation failure: includes power loss, device malfunction.A device left plugged in and still in the "on' position will restart if the power returns, unless there was other damage to the unit, which would have triggered an alarm.* alerts & alarms for low oxygen purity * alerts & alarms for low or loss of flow due to obstruction of the gas path (i.E., tubing kinked) the devilbiss product models 525, 1025 and igo 306 all have these alarm systems.It is stated in the instructions for use, and also clearly stated that "the device is not intended for life support, nor does it provide any patient monitoring capabilities".There is no claim or evidence of a patient injury and no evidence the devilbiss device was being used by a patient at the time of the adverse event.

Event Description

Devilbiss is the manufacturer of the below noted device on medwatch report mw5078382.We find the concerns unsubstantiated and have addressed them.A voluntary event report was filed, mw5078382, patient mr.(b)(6) reported against various brand of oxygen concentrators such as inogen, invacare, philips, respironics and devilbiss.Event was described in the report: "this is a safety concern.The unit fails to monitor oxygen to the pt.After further checking i found that none of the following manufactured oxygen concentrators monitored the oxygen to the pt; inogen phillips invacare drive was also found to not restart after a power failure.This can cause a pt to unknowingly go without oxygen.I recommend that all machines be recalled and fixed and not used until this safety concern is solved".

• Brand Name: DEVILBISS
• Type of Device: OXYGEN CONCENTRATOR
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: figueroa ; 100 devilbiss drive; somerset, PA 15501 ; 8003381988
• MDR Report Key: 7814115
• MDR Text Key: 118269827
• Report Number: 2515872-2018-00005
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K172648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1