MAUDE Adverse Event Report: INVACARE TAYLOR STREET 5LTR PLAT CONC W/SESO2 AND HFIIC 9153629597; GENERATOR, OXYGEN, PORTABLE

Model Number NA:IRC5LXO2

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Invacare was notified of the incident by an attorney.Invacare requested the concentrator be returned but was informed the attorney is having chase pellegrin of medical equipment repair in mandeville inspect the concentrator, and potentially do destructive testing of the unit.The concentrator will not be returned to invacare at this time.Vgm insurance company did a preliminary inspection and stated the concentrator functioned properly.The user manual part #1193322-a-04 page 5 states: intended use: the intended function and use of the invacare® perfecto2¿v oxygen concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.It is not intended to sustain or support life.Danger! risk of injury or death this product is to be used as an oxygen supplement and is not intended to be life-supporting or life-sustaining.Only use this product if the patient is capable of spontaneous breath, able to inhale and exhale without the use of a machine.Should additional information become available, a supplemental record will be filed.

Event Description

The patient was using a (b)(6) year old irc5lx02 oxygen concentrator that at some point allegedly malfunctioned.The patient switched to her back up supply of oxygen until it was depleted.The patient was found deceased.

• Brand Name: 5LTR PLAT CONC W/SESO2 AND HFIIC 9153629597
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 9921938
• MDR Text Key: 186346501
• Report Number: 1525712-2020-00012
• 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: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:IRC5LXO2
• Device Catalogue Number: IRC5LXO2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/1997
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death