MAUDE Adverse Event Report: DRIVE; CONSERVER, OXYGEN

Model Number	P-224
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
We are submitting this report in response to medwatch file number (b)(4).The device was not being used on patient.A healthcare worker identified the missing membrane upon visual inspection of the device and disposed of device prior to being used.Describe potentially hazardous event and potential adverse health outcome if applicable: an oxymizer pendant with missing reservoir membrane will allow some volume of oxygen from the supply source to leak out of the reservoir vents into the ambient environment.Use of an oxymizer pendant missing the membrane may cause a reduction in the net amount of supplemental oxygen delivered to the patient.A reduced amount of oxygen to the patient may result a lower than anticipated blood oxygen level.Describe any factors related to the occurrence of potentially hazardous events such as device or other product related factors or user related factors that put the population at greater risk.The presence of fire or an ignition source, such as a patient smoking while using or near the device may lead to personal injury and/or property damage.A lower than anticipated amount of delivered oxygen to a patient may result in mild, reversible conditions, such as hypoxemia, shortness of breath and/or feelings of dyspnea.Rationale for reportability assessment: in this case, there was no adverse event; the device was not used on a patient, as the missing membrane was discovered by simple visual inspection and discarded prior to use.However, in response the medwatch filing, an mdr filing is appropriate to provide details of the device and health risk.Use of an oxymizer pendant without a reservoir membrane may reduce the total amount of oxygen delivered to the patient, although a flow of oxygen will continue to be delivered to the patient.The oxymizer pendant is an oxygen accessory and is not life supporting or life sustaining.A lower than anticipated amount of delivered oxygen to a patient may result in mild, reversible conditions, such as hypoxemia, shortness of breath and/or feelings of dyspnea we are awaiting receipt of product to be evaluated for conformance.
Event or Problem Description
We are submitting this report in response to medwatch file number (b)(4).The device was not being used on patient.A healthcare worker identified the missing membrane upon visual inspection of the device and disposed of device prior to being used.Describe potentially hazardous event and potential adverse health outcome if applicable: an oxymizer pendant with missing reservoir membrane will allow some volume of oxygen from the supply source to leak out of the reservoir vents into the ambient environment.Use of an oxymizer pendant missing the membrane may cause a reduction in the net amount of supplemental oxygen delivered to the patient.A reduced amount of oxygen to the patient may result a lower than anticipated blood oxygen level.Describe any factors related to the occurrence of potentially hazardous events such as device or other product related factors or user related factors that put the population at greater risk.The presence of fire or an ignition source, such as a patient smoking while using or near the device may lead to personal injury and/or property damage.A lower than anticipated amount of delivered oxygen to a patient may result in mild, reversible conditions, such as hypoxemia, shortness of breath and/or feelings of dyspnea.Rationale for reportability assessment: in this case, there was no adverse event; the device was not used on a patient, as the missing membrane was discovered by simple visual inspection and discarded prior to use.However, in response the medwatch filing, an mdr filing is appropriate to provide details of the device and health risk.Use of an oxymizer pendant without a reservoir membrane may reduce the total amount of oxygen delivered to the patient, although a flow of oxygen will continue to be delivered to the patient.The oxymizer pendant is an oxygen accessory and is not life supporting or life sustaining.A lower than anticipated amount of delivered oxygen to a patient may result in mild, reversible conditions, such as hypoxemia, shortness of breath and/or feelings of dyspnea.Inspection of product has been performed.Product is conforming.This incident is deemedan isolated incident.

• Brand Name: DRIVE
• Common Device Name: CONSERVER, OXYGEN
• MDR Report Key: 12377907
• Report Number: 1062191-2021-00001
• Device Sequence Number: 4067874
• Product Code: NFB
• UDI-Device Identifier: 00822383274508
• UDI-Public: 822383274508
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: P-224
• Device Lot Number: 10 210493
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 08/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1