MAUDE Adverse Event Report: INVACARE FLORIDA PERFECTO2 V WITH SENSOR 9153650799; GENERATOR, OXYGEN, PORTABLE

Model Number NA:IRC5PO2V

Device Problems Inaccurate Flow Rate (1249); Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

Manufacturer Narrative

Invacare was made aware of an event in the (b)(6) involving an irc5po2awn stationary concentrator which was manufactured by invacare (b)(4) in (b)(6) of 2012.Invacare (b)(4) is no longer in business, therefore, this report is being filed under invacare (b)(4) where the concentrators are currently manufactured.Invacare is filing this report because the irc5lxo2v, made at invacare owned sanford and sold in the us has been determined to be similar in design to the reported device.Invacare has attempted to obtain further information without success.The sequence of events is not yet known and its not clear if the device was being used by the patient at the time of their passing.The device has been returned to invacare uk and is currently awaiting further evaluation.A follow up will be filed when further information is obtained.

Event Description

Invacare europe was notified by the customer we have been informed by clinician that they are currently investigating a patient death.They are investigating into this patient as they have logged that the patient passed away but there was a problem with the concentrator and the ambulance attended.

Manufacturer Narrative

The exact circumstances of this incident are still unknown.We received additional information from invacare europe, regarding the evaluation of the irc5po2awn concentrator by the bedford repair center.The device went into failure mode due to internal problems resulting in too low of oxygen delivery performance, giving an audible and visual red-light alarm before shutting down accordingly.The alarm system on the unit worked as it should, alerting the user to switch (if needed) to a backup source of oxygen before the device shutdown.

Event Description

Invacare europe was notified by the customer ¿we have been informed by clinician that they are currently investigating a patient death.They are investigating into this patient as they have logged that the patient passed away but there was a problem with the concentrator and the ambulance attended.¿.

• Brand Name: PERFECTO2 V WITH SENSOR 9153650799
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• MDR Report Key: 12039849
• MDR Text Key: 257429986
• Report Number: 1031452-2021-00022
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:IRC5PO2V
• Device Catalogue Number: IRC5PO2V
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death